7,889 Pharmaceutical Compliance jobs in the United States

Senior Regulatory Affairs Specialist - Pharmaceutical Compliance

33601 Tampa, Florida $115000 Annually WhatJobs

Posted 4 days ago

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full-time
Our client, a dynamic and rapidly growing pharmaceutical company dedicated to improving global health, is seeking a highly experienced Senior Regulatory Affairs Specialist to join their critical compliance team in Tampa, Florida, US . This pivotal role involves ensuring that all company products and processes meet stringent regulatory requirements across various international markets. The ideal candidate will possess a deep understanding of pharmaceutical regulations, a meticulous attention to detail, and a proven track record in preparing and submitting regulatory dossiers.

Key Responsibilities:
  • Develop and implement global regulatory strategies for product development and lifecycle management.
  • Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, CTAs, MAAs) to health authorities worldwide (e.g., FDA, EMA, Health Canada).
  • Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
  • Monitor and interpret evolving regulatory guidelines and advise internal teams on compliance implications.
  • Manage regulatory submissions, ensuring timely and accurate completion according to established timelines.
  • Liaise directly with regulatory agencies on behalf of the company, responding to queries and facilitating approvals.
  • Review and approve labeling, promotional materials, and advertising for regulatory compliance.
  • Conduct regulatory due diligence for potential partnerships, acquisitions, and licensing agreements.
  • Contribute to the development and maintenance of Standard Operating Procedures (SOPs) related to regulatory affairs.
  • Train and mentor junior regulatory affairs personnel.
  • Stay informed about emerging regulatory trends and their potential impact on the company's product portfolio.

Qualifications:
  • Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; Advanced degree (Master's or Pharm.D.) is preferred.
  • Minimum of 7 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Comprehensive knowledge of global pharmaceutical regulatory requirements and submission processes.
  • Proven experience in preparing and managing successful regulatory submissions.
  • Familiarity with ICH guidelines and regional regulatory frameworks.
  • Excellent analytical, organizational, and problem-solving skills.
  • Strong written and verbal communication abilities, with a talent for clear and concise documentation.
  • Ability to work independently and collaboratively in a cross-functional team environment.
  • Proficiency in regulatory information management systems is a plus.
  • High level of integrity and ethical conduct.
This is a prime opportunity to significantly contribute to bringing life-changing therapies to patients worldwide.
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Packaging Technician (Pharmaceutical Industry)

45071 West Chester, Ohio Kelly Services, Inc.

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> For those who want to keep growing, learning, and evolving. We at Kelly hear you, and were here for you! Were seeking a Packaging Technician II to work at a cutting-edge pharmaceutical company, in West Chester. Sound good? Take a closer look bel Packaging Technician, Technician, Pharmaceutical, Industry, Packaging, Staffing

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Packaging Technician (Pharmaceutical Industry)

45069 Wetherington, Ohio Kelly Services

Posted 2 days ago

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For those who want to keep growing, learning, and evolving. We at Kelly® hear you, and we're here for you! We're seeking a **Packaging Technician II** to work at a **cutting-edge pharmaceutical company, in West Chester** . Sound good? Take a closer look below. You owe it to yourself to consider this great new opportunity.
**Salary/Pay Rate/Compensation:**
$23 Per hr. on Days $am-6:30pm on a 2-2-3 schedule
OR
26 per hr. on nights 6pm-6:30am on a 2-2-3 schedule
Temp to Hire positions thru Kelly Services
**Why you should apply to be Packaging Technician II:**
- Join a dynamic team committed to excellence in the pharmaceutical industry.
- Work in a safe and compliant environment with a strong emphasis on cGMP standards.
- Opportunities for professional development and training in advanced manufacturing techniques.
- Be part of a culture that values innovation and continuous improvement.
**What's a typical day as Packaging Technician II? You'll be:**
- Operating assigned machinery, including automated inspection equipment, while ensuring a smooth flow of product.
- Conducting manual visual, cosmetic, and physical inspections of materials, and promptly escalating concerns to the Lead or Manager/Supervisor.
- Performing cleaning, housekeeping, and line clearance activities to maintain a compliant cGMP environment.
**This job might be an outstanding fit if you:**
- Have a high school diploma or equivalent; additional certifications in manufacturing or related fields are a plus.
- Possess strong attention to detail and the ability to follow SOPs, cGMPs, and safety procedures.
- Are capable of operating material handling equipment, such as motorized and manual pallet jacks.
**What happens next**
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about, so let's get to work. Apply to be **Packaging Technician II** today!
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Get a complete career fit with Kelly ® .
You're looking to keep your career moving onward and upward, and we're here to help you do just that. Our staffing experts connect you with top companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in your career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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Project Manager Capital Projects (Pharmaceutical Industry)

07065 Rahway, New Jersey PharmEng Technology

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About the job Project Manager Capital Projects (Pharmaceutical Industry) Job Title: Project Manager Capital Projects (Pharmaceutical Industry)Location: Rahway, NJType: Full-TimeAbout the Role:We seek a motivated Project Manager to support capital projects within the pharmaceutical industry. This role involves coordinating facility upgrades, equipment installations, and infrastructure improvements, ensuring timely execution and regulatory compliance. The successful candidate will work closely with cross-functional teams and external vendors to drive project success.Key Responsibilities:Assist in planning, executing, and monitoring capital projects related to facility upgrades and infrastructure improvements.Collaborate with engineering, quality, procurement, and production teams to align projects with company objectives.Develop and track project plans, schedules, and budgets.Monitor project progress, manage risks, and provide updates to senior management.Support procurement of materials and services, ensuring adherence to company policies and regulations.Prepare documentation, reports, and presentations for project reviews and meetings.Maintain compliance with GMP, FDA regulations, and industry standards.Qualifications:Bachelor's degree in Engineering, Construction Management, or a related field.1-3 years of project management experience, preferably in the pharmaceutical or manufacturing industries.Basic knowledge of capital projects, including budgeting, scheduling, and risk management.Strong organizational and communication skills.Proficiency in project management software and Microsoft Office (Excel, PowerPoint, Word).Preferred Qualifications:Familiarity with GMP, FDA, and regulatory guidelines in pharmaceutical manufacturing.Project Management Professional (PMP) certification or equivalent training.Apply Now:Join our team to lead impactful projects and contribute to advancements in pharmaceutical manufacturing. If you are detail-oriented and driven, we encourage you to apply!

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Sr. R&D Director (Pharmaceutical Industry)

53208 Milwaukee, Wisconsin Actalent

Posted 9 days ago

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Job Description

Sr. Director of Research & Development
Direct Hire | Relocation Offered | Excellent Benefits
Description
Will be responsible for developing new pharmaceutical products from concept to commercialization that support company growth. Position will also enhance and improve upon current products. Serves as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. Is responsible for formulation and generation of representative pilot samples for internal and external customer evaluations
Duties:
+ Formulates new products from development to commercialization within defined company, industry, and regulatory parameters
+ Evaluates raw materials
+ Establishes specifications for new and/or reformulated products
+ Changes existing formulations to improve product cost
+ Perform scale-up for transition to manufacturing
+ Develops new technologies related to pharmaceutical processing
+ Writes necessary documents for manufacturing feasibility
+ Prepares product registration documentation and product chemistry packages to meet regulatory requirements
+ Responsible for batch production from pilot scale to process validation
+ Additional duties as required
Knowledge, Skills & Abilities:
+ Minimum of a BS in Chemistry, Pharmacy, or other Science
+ 5+ years of experience in pharmaceutical formulation development
+ 5+ years of experience in pharmaceutical management
+ 10+ years of experience in the pharmaceutical industry
+ Proven problem-solving skills and track record of successful technical accomplishments
+ Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry
+ Experience with FDA and other regulatory agencies required
+ Experience with ANDA, ANADA, IND, and INAD submissions preferred
+ Experience with HPLC testing and other stability testing preferred
Experience Level
Expert Level
Pay and Benefits
The pay range for this position is $18000.00 - $22000.00/yr.
Good stuff with this company! Trust me!
Workplace Type
This is a fully onsite position in Milwaukee,WI.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Sr. R&D Director (Pharmaceutical Industry)

53786 Madison, Wisconsin Actalent

Posted 9 days ago

Job Viewed

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Job Description

Sr. Director of Research & Development
Direct Hire | Relocation Offered | Excellent Benefits
Description
Will be responsible for developing new pharmaceutical products from concept to commercialization that support company growth. Position will also enhance and improve upon current products. Serves as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. Is responsible for formulation and generation of representative pilot samples for internal and external customer evaluations
Duties:
+ Formulates new products from development to commercialization within defined company, industry, and regulatory parameters
+ Evaluates raw materials
+ Establishes specifications for new and/or reformulated products
+ Changes existing formulations to improve product cost
+ Perform scale-up for transition to manufacturing
+ Develops new technologies related to pharmaceutical processing
+ Writes necessary documents for manufacturing feasibility
+ Prepares product registration documentation and product chemistry packages to meet regulatory requirements
+ Responsible for batch production from pilot scale to process validation
+ Additional duties as required
Knowledge, Skills & Abilities:
+ Minimum of a BS in Chemistry, Pharmacy, or other Science
+ 5+ years of experience in pharmaceutical formulation development
+ 5+ years of experience in pharmaceutical management
+ 10+ years of experience in the pharmaceutical industry
+ Proven problem-solving skills and track record of successful technical accomplishments
+ Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry
+ Experience with FDA and other regulatory agencies required
+ Experience with ANDA, ANADA, IND, and INAD submissions preferred
+ Experience with HPLC testing and other stability testing preferred
Experience Level
Expert Level
Pay and Benefits
The pay range for this position is $18000.00 - $22000.00/yr.
Good stuff with this company! Trust me!
Workplace Type
This is a fully onsite position in Madison,WI.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Sr. R&D Director (Pharmaceutical Industry)

55405 Saint Paul, Minnesota Actalent

Posted 9 days ago

Job Viewed

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Job Description

Sr. Director of Research & Development
Direct Hire | Relocation Offered | Excellent Benefits
Description
Will be responsible for developing new pharmaceutical products from concept to commercialization that support company growth. Position will also enhance and improve upon current products. Serves as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. Is responsible for formulation and generation of representative pilot samples for internal and external customer evaluations
Duties:
+ Formulates new products from development to commercialization within defined company, industry, and regulatory parameters
+ Evaluates raw materials
+ Establishes specifications for new and/or reformulated products
+ Changes existing formulations to improve product cost
+ Perform scale-up for transition to manufacturing
+ Develops new technologies related to pharmaceutical processing
+ Writes necessary documents for manufacturing feasibility
+ Prepares product registration documentation and product chemistry packages to meet regulatory requirements
+ Responsible for batch production from pilot scale to process validation
+ Additional duties as required
Knowledge, Skills & Abilities:
+ Minimum of a BS in Chemistry, Pharmacy, or other Science
+ 5+ years of experience in pharmaceutical formulation development
+ 5+ years of experience in pharmaceutical management
+ 10+ years of experience in the pharmaceutical industry
+ Proven problem-solving skills and track record of successful technical accomplishments
+ Strong understanding of cGMP guidelines and FDA regulations related to the pharmaceutical industry
+ Experience with FDA and other regulatory agencies required
+ Experience with ANDA, ANADA, IND, and INAD submissions preferred
+ Experience with HPLC testing and other stability testing preferred
Experience Level
Expert Level
Pay and Benefits
The pay range for this position is $18000.00 - $22000.00/yr.
Good stuff with this company! Trust me!
Workplace Type
This is a fully onsite position in Minneapolis,MN.
Application Deadline
This position is anticipated to close on Aug 29, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
View Now
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Sr. R&D Director (Pharmaceutical Industry) (Minneapolis)

55401 Minneapolis, Minnesota Actalent

Posted 3 days ago

Job Viewed

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Job Description

full time

Job Description

Sr. Director of Research & Development

Direct Hire | Relocation Offered | Excellent Benefits

Description

Will be responsible for developing new pharmaceutical products from concept to commercialization that support company growth. Position will also enhance and improve upon current products. Serves as a technical expert supporting product improvements, quality enhancements, customer requests, and cost-saving initiatives. Responsible for formulation and generation of pilot samples for internal and external evaluations.

Duties :
  • Formulates new products from development to commercialization within defined company, industry, and regulatory parameters
  • Evaluates raw materials
  • Establishes specifications for new and/or reformulated products
  • Modifies existing formulations to improve product cost
  • Performs scale-up for transition to manufacturing
  • Develops new technologies related to pharmaceutical processing
  • Prepares documents for manufacturing feasibility
  • Prepares registration documentation and chemistry packages to meet regulatory requirements
  • Oversees batch production from pilot to process validation
  • Performs additional duties as required
Knowledge, Skills & Abilities :
  • Minimum of a BS in Chemistry, Pharmacy, or related Science
  • 5+ years in pharmaceutical formulation development
  • 5+ years in pharmaceutical management
  • 10+ years in the pharmaceutical industry
  • Proven problem-solving skills and successful technical accomplishments
  • Strong understanding of cGMP guidelines and FDA regulations
  • Experience with FDA and other regulatory agencies required
  • Experience with ANDA, ANADA, IND, and INAD submissions preferred
  • Experience with HPLC testing and stability testing preferred
Experience Level

Expert Level

Pay and Benefits

Salary range: $180,000 - $220,000 per year.

This is a fully onsite position in Minneapolis, MN.

Application Deadline

Closing on August 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services, supporting innovation and speed to market. We are an equal opportunity employer.

For accommodations, contact:

#J-18808-Ljbffr
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Senior Compliance Officer (or Compliance Officer)

60290 Chicago, Illinois Golub Capital

Posted 3 days ago

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Job Description

Position Information

Hiring Manager:
Senior Counsel
Department:
Legal & Compliance
Position Responsibilities

The Firm acts as an investment adviser to onshore and offshore private funds, managed accounts and both public and private business development companies. The Firm is seeking a Senior Compliance Officer to lead certain aspects of the Firm's compliance program. A thorough understanding of the Firm's products, services and regulatory framework is necessary in this role. This person will lead and manage routine and special projects on behalf of the broader Legal & Compliance Department.

Primary responsibilities of this position will be:
  • Act as subject matter expert overseeing monitoring and testing of the Firm's regulatory compliance controls
  • Establish and enhance compliance standards and design and implement improvements to internal control structures
  • Develop and execute special or enhanced monitoring and testing techniques for new, complex or high-risk requirements, or in response to certain weaknesses discovered through routine assessments, testing, audits or exams
  • Manage and complete regulatory filings
  • Review advertising and sales materials, correspondence, investor communications and investor reports and other documents to ensure that these materials meet SEC advertising regulations and other regulatory rules, as applicable, and internal quality control standards
  • Investigate and resolve compliance-related issues and advise Senior Management and Board on compliance matters
  • Assess control design and effectiveness to mitigate compliance risk
  • Manage certain special projects related to the Legal & Compliance Department as needed, e.g., policy updates due to regulatory changes, research and recommend solutions related to compliance matters
  • Serve as a subject matter expert on the implementation and execution of testing regulatory compliance controls
  • Effectively communicate compliance-related issues requiring management attention
  • Stay apprised of regulatory matters and developments through reading, research and training through online webinars and conferences and assist with exam preparedness efforts
  • Collaborate internally with other members of the Legal & Compliance Department to ensure consistent standards and effective communication
Candidate Requirements

Qualifications & Experience:
  • Bachelor's degree or equivalent education required; JD from a top-tier institution is preferred but not required
  • At least 8 years of relevant experience including experience with the Investment Advisers Act of 1940 and / or the Investment Company Act of 1940
  • Knowledge and understanding of regulatory and industry best practices developments, particularly in the areas of compliance, corporate governance and risk management
  • Preference for previous exposure to, and broad understanding of, the credit asset management business
  • Strong analytical skills with experience in prioritization, issue identification and resolution
  • Strong project management skills, ability to review materials quickly and ability to drive and meet deadlines
  • Skilled in business writing and editing with strong attention to detail
  • Quick learner who has an ability to grasp complicated financial concepts
  • Capacity and passion for being part of a fast-growing, multi-office environment
  • Team oriented with the ability to build relationships and earn the respect of others
  • Self-starter with the ability to manage projects independently
  • Ability to handle sensitive matters at all levels of the organization with discretion and confidentiality
  • Ability to anticipate and react quickly to the evolving financial services regulatory environment
  • Demonstrated knowledge base and stature to deliver solution-oriented advice in a manner that is respected and valued by business and staff group leaders and constituents
  • Enthusiastic about working in office and creating a Gold Standard hybrid work culture
Critical Competencies for Success

Our Gold Standards Model defines key behaviors and competencies across 4 dimensions: Leadership, Achieving Results, Personal Effectiveness and Thinking Critically. These behaviors and competencies drive our ability to win together.
  • Leadership: Role models in this area consistently focus on the right goals and priorities and continually develop themselves and others. Always team players, they influence and engage with others to contribute to a supportive and inclusive culture where all feel welcome.
  • Achieving Results: Role models in this area are high achievers who develop careful plans and deliver consistently and effectively. They hold themselves and others accountable for delivering high quality results, and they remove barriers to ensure others can contribute and grow.
  • Personal Effectiveness: Role models in this area build strong relationships, treat others with respect and communicate effectively. They are driven to exceed expectations and are adaptable to changing circumstances.
  • Thinking Critically: Role models in this area understand our business, rely on analytical reasoning and seek diverse perspectives to solve problems. They are forward thinking, anticipating issues and addressing them in advance.
The department-specific competencies define the knowledge, skills and abilities that are needed to successfully perform the functional or technical work of this role.
  • Industry Knowledge: Demonstrates an understanding of the Firm's position in the industry, including its complex structure and competitive advantage in the marketplace. Monitors industry trends and changes and recognizes their relevancy and implications.
  • Technical Communication and Documentation: Documents and communicates technical processes and procedures in area of specialty to stakeholders. Adapts the level of detail and specificity based on the needs of the intended audience.
  • Compliance: Ensures compliance with laws and regulations and stays current with legislative and regulatory changes that impact the Firm.
  • Contract Management: Leverages an understanding of the regulatory, legal and compliance elements of contracting to interpret and ensure adherence to contract agreements throughout the lifecycle of agreements.
  • Negotiation: Applies advanced negotiating techniques and a consultative approach with customers and internal stakeholders to compliantly create measurable short- and long-term values that leads to mutually beneficial outcomes.
  • Project / Program Management: Manages projects and / or programs through planning, identifying resources, monitoring and communicating project activities and assessing impacts of project decisions.


Compensation and Benefits
For Illinois Only: It is expected that the base salary range for this position will be $220,000 to $80,000 for a Senior Compliance Officer and 150,000 to 200,000 for a Compliance Officer. Actual salaries may vary based on factors such as skills, experiences and qualifications for the role. The total compensation package for this position may also include other elements and discretionary awards in addition to a full range of medical, financial and / or other benefits (including 401(k) eligibility and various paid time off benefits such as vacation, sick time and parental leave) dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, the employee will be in an 'at-will position' and the Firm reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance, Firm or individual department / team performance and market factors.

Golub Capital is an Equal Opportunity Employer.

Due to the highly regulated nature of Golub Capital's business and because of the sensitivity of the information that all personnel have access to, Golub Capital performs extensive and thorough pre-hire screens to ensure that its personnel act with expected levels of integrity, professionalism and personal responsibility.
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