1,199 Financial Regulations jobs in the United States

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

The Regulatory Affairs Manager V (Regulatory Affairs) for the JPM CBRN Task Order 3 contract shall serve as a liaison at the One RAQA Program Office, between the AJPEO MRAS regulatory office and product leads to ensure DoD-funded regulatory Sponsors developing MCMs are complying with relevant laws, regulations, and current guidance.

Essential Job Functions:

• Serve as a subject matter expert in regulatory affairs at the working group-level to inform innovative regulatory approaches to develop MCMs against emerging threats.
• Elevate critical programmatic and project level regulatory challenges to the AJPEO MRAS regulatory office on critical programmatic and project level regulatory challenges.
• Provide training and advisement to DOD staff on regulations, authoring regulatory documents, and interactions with regulatory authorities.
• Provide input to Sponsors' regulatory documents for submission to FDA or other National Regulatory Authorities (NRAs) and coordinates/prepares and maintains FDA filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.) in accordance with US FDA or other National Regulatory Authority requirements and with the eCTD submission format, as applicable.
• Review, draft, manage, maintain and retain regulatory documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with Regulatory Agencies, official briefing packages, submissions, and other relevant regulatory documentation) in accordance with approved business rules in the assigned electronic document management system.
• Contribute to the modification, development and implementation of internal policies and procedures.
• Represent the regulatory team, provide regulatory guidance to assigned product teams, and facilitate cross-communication with the interdisciplinary team. In addition, the contractor shall present, orally and in writing, the outcome of these efforts in a timely manner and participates in regulatory audits/inspections as required.
• Plan, prepare and execute meetings with regulatory agencies on complex and strategic programs; negotiate complex issues with regulatory bodies Provide advice and aid in the implementation of quality systems and procedures to ensure compliance with all applicable laws, regulations, and organizational quality standards in support of advanced development activities.
• Conducts quality audits and oversight, as assigned for non-clinical and/or clinical and/or manufacturing activities in compliance with relevant laws, regulations and policies.
• Create and/or review acquisition and contract documents ((e.g., Requests for Proposals (RFPs), Source Selection Evaluation Boards (SSEBs), etc.).) to ensure regulatory and quality requirements are appropriate and consistent with FDA regulations and assess the impact of these requirements to the product development timeline.
• Collaborate and network with internal/external regulatory professionals and clinicians, as well as investigators and researchers, and other scientific and technical disciplines to maintain current knowledge in the Chemical, Biological, Radiological, and Nuclear (CBRN), Emerging Infectious Disease (EID), and other relevant emerging and re-emerging threat spaces.
• Travel for presentations and seminars, and to observe and provide regulatory assessments of supplier evaluation visits (e.g., due diligence, mock audits, vendor qualifications, etc.).

Necessary Skills and Knowledge:

• Shall possess the ability to work on a multi-disciplined team in a DoD acquisition environment.
• Possess the ability to perform multiple task simultaneously and rapidly redirect efforts based on changing requirements.
• The contractor shall possess strong writing and oral communication skills.

Minimum Qualifications:

• Bachelor's or Master's degree in Life Sciences, Public Health, Medical, Nursing, Pharmacy, Veterinary, Epidemiology or a related discipline, as well as fifteen (15) years of general experience and ten (10) years of relevant experience.
• Experience in developing and implementing regulatory strategies and overseeing regulatory filings (such as INDs, NDA, BLAs, PMA, 510(k), EUA, etc.).
• Experience with providing critical review of documentation supporting regulatory applications.
• Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e. g. FDA regulations, ICH guidelines).
• Experience with medical product development requirements under the FDA Animal Rule regulatory pathway, including animal model development, pharmacokinetics, pharmacodynamics, and toxicity.
• Mastery of FDA and other relevant regulatory authorities' requirements for clinical study development and implementation and marketing and post- marketing.
• Experience applying this expert knowledge to products made available through normal approval processes or emergency use mechanisms.
• Clearance: Secret

Preferred Qualifications:

• Certification in Regulatory Affairs or other certification relevant to medical product development and/or auditing is desired and will be at no cost to the Government.

Pay and Benefits:

The salary range for this position is $150,000- $170,000 annually. At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.

Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs in Endocrinology Rare Disease and Oncology. Here at Ascendis, we pride ourselves on exceptional science, visionary leadership, and skilled and passionate colleagues. Guided by our core values of Patients, Science, and Passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs. Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We offer a dynamic workplace for employees to grow and develop their skills. The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies with focus on America’s and the clinical, and non-clinical disciplines. Ensures timely preparation of organized and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Requires ability to work strategically, both independently and in a team environment. The position will be based in Palo Alto, CA. Key Responsibilities Responsible for strategic and operational regulatory input for cross functional (non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues. Contributes to the development of global clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and product expansion. Acts as the company representative with regulatory authorities covering America’s Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs. Excellent organizational skills and ability to work on and/or oversee a number of projects with tight timelines. Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams. Work both independently and by supporting the regulatory project team Contribute to internal regulatory policies and procedures to achieve best practices and work processes. BS/BA Degree in a Scientific Discipline, Advanced Degree required. Minimum of 10 years overall regulatory experience and preferably including experience managing investigational and marketed products. Prior experience representing Regulatory Affairs on cross-functional teams is desirable. Must be capable of effectively leading teams in preparation of submissions. Experience working on international teams desirable. Experience working on international submission desirable. Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business. Must be capable of critically reviewing complex technical documents and influencing colleagues across functions. Experience with drug-device combination products preferred. Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing applications is a plus. Ability to travel up to 10-20% of the time domestically and internationally, since part of the Regulatory Affairs organization is located in Princeton, Palo Alto and Denmark. Salary Range - $225-240K/year A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged. 401(k) plan with company match Medical, dental, and vision plans Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of Pet Insurance and Legal Insurance Employee Assistance Program Employee Discounts Professional Development Health Saving

Join to apply for the Regulatory Affairs Manager role at Celldex

Join to apply for the Regulatory Affairs Manager role at Celldex

Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory and autoimmune disorders. As our pipeline progresses toward major regulatory milestones, we are seeking a highly motivated Regulatory Affairs Manager to join our growing Regulatory Affairs team.

This role is essential to supporting the increasing volume of regulatory activities and will serve as a key partner on clinical study teams and cross-functional working groups. With a U.S. focused scope, the Regulatory Affairs Manager will contribute to the development and execution of regulatory strategies, the preparation of high-quality submission packages, and the operational coordination of key deliverables in collaboration with the broader Regulatory Affairs team.

Responsibilities

• Support the planning, coordination, and execution of regulatory submissions, including INDs, amendments, annual reports, and other regulatory documentation for U.S. programs
• Serve as a Regulatory Affairs representative on clinical study teams and cross-functional project teams, ensuring alignment and timely delivery of regulatory deliverables
• Assist in authoring, reviewing, and compiling high-quality submission packages in accordance with FDA and ICH guidelines
• Interpret scientific data and study results to support the development of clear, concise regulatory documents
• Collaborate cross-functionally with Clinical Development, CMC, Quality, Program Management, and external partners to track and meet regulatory timelines
• Maintain up-to-date knowledge of U.S. regulatory requirements, guidance, and industry best practices
• Ensure submission content complies with applicable regulations, standards, and internal quality expectations
• Contribute to internal process improvements and department best practices to ensure operational excellence
  
  

• Bachelors degree in Life Sciences, Biotechnology, Pharmacy, or a related field is required; advanced degree is a plus
• 46 years of experience in drug development, with at least 2 years in Regulatory Affairs preferred
• Prior involvement in cross-functional clinical development teams; experience with regulatory submissions (INDs, amendments) is highly desirable
• Strong understanding of U.S. regulatory frameworks and familiarity with FDA 21 CFR, ICH, and EMA guidelines
• Excellent project management and communication skills; ability to manage multiple priorities effectively and adapt to shifting timelines
• Demonstrated ability to interpret complex scientific data and translate it into regulatory language
• Self-motivated, organized, and detail-oriented with a proactive and solution-oriented mindset
• Proficient in Microsoft Office and regulatory documentation tools
  
  

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Legal

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• Lead, mentor, and manage the Regulatory Affairs (RA) team, including performance reviews, workload planning, and professional development.
• Develop and implement global regulatory strategies for new and existing IVD products (Class A to D/Class I to III), including antibodies and diagnostic systems, in key markets (EU, LATAM, Asia, MDSAP-participating countries).
• Act as the primary RA liaison for product submissions and regulatory strategy across LATAM, the EU (IVDR), MDSAP-participating countries, and Asia.
• Oversee preparation, submission, and maintenance of regulatory documentation, including CE Mark, Health Canada, ANVISA, NMPA, MFDS, and other country-specific filings.
• Write and manage compliant technical documentation (LATAM, the EU (IVDR), MDSAP-participating countries, and Asia) and ensure timely internal review and approval.
• Collaborate closely with R&D to embed regulatory requirements throughout the product design and development lifecycle.
• Provide strategic regulatory input and serve as the company representative in interactions with regulatory agencies and notified bodies.
• Review and approve technical file deliverables (e.g., validation protocols, V&V reports, PMS reports, literature reviews) to ensure compliance with IVDR and other global requirements.
• Ensure timely development and delivery of high-quality regulatory documents, including GSPRs, gap assessments, risk management documentation, and post-marketing surveillance reports.
• Deliver internal training on global regulatory requirements, with a strong emphasis on IVDR.
• Leverage eQMS experience to support implementation and ensure ongoing regulatory compliance, system integrity, and alignment with global quality standards.
• Develop and maintain regulatory SOPs, guidance documents, and templates; lead and deliver company-wide and RA team-specific compliance and regulatory training.
• Support the compliance and CAPA team.
• Identify and implement process improvements to enhance department efficiency, documentation quality, and regulatory compliance.
• Track and report on the status of regulatory deliverables to senior management; participate in management reviews.
• Support external audits and inspections by coordinating with notified bodies and internal teams.
• Update existing legacy technical files to ensure compliance with IVDR requirements, including format, content, and risk documentation.
• Maintain up-to-date knowledge of global regulatory requirements, industry trends, and evolving standards.
• Serves as the designated PRRC under the EU IVDR, ensuring the company's full compliance with all applicable regulatory requirements throughout the product lifecycle, including review of technical documentation, vigilance activities, and acting as the primary liaison with regulatory authorities.
• Promote a culture of regulatory excellence and continuous improvement across the organization.
• Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings
• Oversee coordination with external regulatory consultants and local agents for international submissions; lead planning and management of the regulatory affairs budget, ensuring alignment with project priorities and organizational goals.
• Other duties as assigned by Management.

• Bachelor's degree or equivalent experience.
• A minimum of five (5+) years working in regulated medical device/IVD or related industry.
• A minimum two (2+) years of management experience required.
• Strong knowledge of international submissions (LATAM, EU, Asia and MDSAP countries).
• Experience with antibody-based diagnostics is strongly preferred.
• Excellent leadership, communication, and project management skills.
• Familiarity with eQMS (MasterControl, Veeva Vault, AssurX) is highly desirable.
• Expert knowledge of the compliance requirements of IVD Regulation 2017/746, NMPA, MFDS, AMDD, etc.
• Knowledge of compliance with harmonized international standards and regulations relevant to IVD devices such as ISO 13485:2016, ISO 14971:2019, MDSAP
• Demonstrates strong analytical, critical thinking, problem solving and investigative skills.
• Excellent interpersonal skills and the ability to work collaboratively with the wider team.
• Excellent organizational skills, attention to detail and an ability to work to tight timelines under minimum supervision.
• Excellent oral and written communication skills.
• Experience with eQMS (MasterControl, AssurX, Veeva Vault QMS).
• Strong computer and internet research literacy with proficiency using Microsoft tools (Word, Excel, PowerPoint, Outlook)

• Onsite - Pacheco, CA
• 8 a.m. to 5 p.m. Monday - Friday. This position may require working extended weekday or weekend hours depending on business needs.

• $100,000 - $150,000 annually

• Company Sponsored Health Insurance - Medical, Dental, Vision
• Company Sponsored Life Insurance
• Voluntary Benefits
• Retirement plan with a match - 401(k)
• PTO
• Paid Holidays
• EAP

• Preparing documentation for international regulatory registrations.
• Preparing technical documentation to compliant to MDD and EU MDR.
• Defining worldwide regulatory requirements are necessary for regulatory approval of products.
• Participating in cross functional teams as regulatory lead.
• Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
• Authoring submissions, researching requirements, setting priorities, and maintaining project schedules.
• Providing guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations.
• Executing on additional responsibilities as defined by management.
• Act as a Subject Matter Expert (SME) to support internal and external audits.

• Bachelor's degree in science, Engineering, or other relevant disciplines.
• Minimum 5-8 years' experience in Regulatory Affairs in the medical device industry.
• FDA, EU, Health Canada, and international registrations experience.
• Working knowledge with quality system regulations and guidelines.
• Ability to develop clear, concise, and timely oral and written reports.
• Great communication skills with all levels of personnel.
• High level of organization and planning skills.
• Working knowledge of medical devices, procedures, and terminology.
• Drug-combination experience a plus.

Regulatory Affairs Manager

Location: Hybrid remote with 2-3 per week in office, must reside in a service area state commutable to Dover, DE; West Palm, FL; or Yulee, FL office locations

What makes us great:

At the heart of our Company is a dedication to delivering energy that drives progress. We put people first, work to keep them safe and build trusting relationships.

What you'll be working on.

The Regulatory Affairs Manager is responsible for the oversight and preparation of Company regulatory proceedings and related analysis, as assigned. The Manager will assist and oversee in developing and implementing new energy projects, rates, and other regulatory strategies within the proceedings as assigned. Responsibilities also include proposing solutions to key business issues, when necessary, and making oral and written testimony and support to federal and state regulatory agencies. This position will oversee and develop team members under his/her direction.

• Responsible for leading regulatory project filings, rate proceedings, and strategic regulatory initiatives.
• Oversee and assist in preparation and support of tools and analysis used in the Company's rate proceeding filings.
• Prepare regulatory filings and petitions before regulatory bodies including the Federal Energy Regulatory Commission, and state Public Service Commissions jurisdictions.
• Prepare and sponsor formal written testimony and data requests relating to all regulatory proceeding filings.
• Prepare rate and revenue analysis, tariffs and rate designs related to regulated rates.
• Work with Federal Energy Regulatory Commission (FERC), state Public Service Commissions (PSC) and Public Counsel/Advocates (OPC) including auditors and staff, along with outside auditors to provide necessary assistance and information.
• Oversee and assist with regulatory strategic planning, and development of rates, programs and filings within the Company's regulatory proceedings.
• Oversee regulatory analysis and other special projects.
• Responsible for the supervision of Regulatory Analysts.
• Perform all other duties assigned by the Assistant Vice President, Regulatory Affairs.

Who you are.

• You have a four-year degree in Accounting, Finance or other related field.
• You possess at least seven to ten years of utility and regulatory affairs experience.
• It would be preferred if you have a background in utility accounting, financial analysis, regulated utility analysis, rates, and/or cost of service.
• You have strong written and verbal communication skills.
• Must be able to respond creatively to unique situations.
• You have a analytical skills and extremely organized.
• You have a wealth of knowledge of company tariffs, rate design, and regulation.
• You have worked with and are proficient in Microsoft Office suite, Epicor suite, UI, FRx and Business Objects.
• You have a high level of initiative, leadership and enjoy self-direction.

Where you'll be working:

• Hybrid remote with ability to commute to Dover, DE; West Palm Beach, FL; or Yulee, FL office locations a few days per week and travel is required.

Benefits/what's in it for you?

• Competitive base salary
• Fantastic opportunities for career growth
• Cooperative, supportive and empowered team atmosphere
• Annual bonus and salary increase opportunities
• Monthly recognition events
• Endless wellness initiatives and community events
• Robust and customizable benefit packages-choose what works best with your life. Options include generous 401k, medical, dental and life insurance, tuition reimbursement, compensated volunteer hours and MORE!
• Paid time off, holidays and a separate