4,197 Regulatory jobs in the United States

Lead the Future of Regulatory Strategy for Rare Diseases.

Are you a strategic regulatory leader ready to shape the development and lifecycle of innovative therapies for rare and serious diseases? Do you thrive in fast-paced, high-impact environments where science, strategy, and global health intersect?

At Alexion, AstraZeneca Rare Disease, we're seeking a Director of Regulatory Affairs - Strategy & Execution to drive the regulatory vision and execution for our most complex and groundbreaking therapies. This is your chance to make an impact at the intersection of cutting-edge science and global health and help patients with urgent unmet medical needs around the world.

What You'll Do

Own and drive regulatory strategy

* Serve as the Regulatory Lead for one or more late-stage or marketed products, leading end-to-end regulatory strategy across the US and/or other key global jurisdictions (EU, UK, Canada).


* Design and implement submission strategies to support product development, registration, and lifecycle management; including INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans, and more.



Be the voice of regulatory leadership

* Lead interactions and meetings with major Health Authorities (FDA, EMA, HC, MHRA), representing Alexion with confidence and credibility.


* Act as a strategic partner to Clinical, Medical Affairs, Commercial, and Global Program Teams, providing regulatory input that shapes development plans and product strategy.



Lead execution of key submissions

* Oversee regulatory documentation, timelines, and team deliverables with precision - ensuring timely and high-quality submissions aligned with regional and global objectives.


* Collaborate cross-functionally with Regulatory Operations, Labeling, and CMC to ensure alignment and success.



Shape the future of regulatory science

* Stay on the pulse of emerging regulatory trends, guidances, and policy shifts. Use your insight to advocate for regulatory innovation and influence internal and external strategy.


* Support enterprise-level regulatory process development, audit readiness, and inspection response.



Inspire, mentor, and lead

* Provide strategic and tactical mentorship to regulatory colleagues and cross-functional team members.


* Contribute to team culture by role-modeling transparency, ethics, and regulatory excellence.



What You'll Bring

* 8+ years of experience in Regulatory Affairs within pharma or biotech, including US regulatory strategy and submissions.


* Proven leadership in global regulatory strategy across the drug development lifecycle, from early development through marketing applications and post-market support.


* Deep understanding of the drug development process, global regulatory frameworks, and rare disease or specialty drug pathways.


* Track record of leading meetings with Health Authorities and managing complex regulatory submissions.


* Strong working knowledge of GxPs, emerging regulations, and regulatory intelligence tools.


* Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments in fast-moving environments.


* Exceptional collaboration and communication skills - able to influence at all levels, including senior leadership.



The annual base pay for this position ranges from $173,600.80 - $260,401.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program (401(k) plan); paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

27-Aug-2025

Closing Date

12-Sept-2025

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Overview

Regulatory Affairs Manager role at Katalyst CRO.

Responsibilities

• Maintain full awareness of regulatory activities on assigned Project(s) and ensure that project deadlines and performance standards are established and met. Work with internal and external stakeholders to manage submission schedules.
• Compile high quality, right first-time submissions (Abbreviated New Drug Applications, New Drug Applications, amendments, supplements, annual reports, etc.). Draft ANDA/NDA modules for original applications, amendments, supplements, etc., for submission to FDA.
• Represent regulatory affairs in project team meetings and provide regulatory guidance to team members to meet scheduling timelines and resolve technical issues.
• Contribute to the preparation of controlled correspondences and meeting packages related to pre- and post-ANDA/IND/NDA meetings with FDA.
• Review technical reports and summary documents; evaluate change controls (chemistry, manufacturing and analytical controls) for appropriate content and formulate strategies with minimal guidance to ensure proper filing categories in accordance with FDA requirements.
• Act as point-of-contact with FDA for exchange of information, as required.
• Assess and remain current with new and changing guidance/regulations.
• Identify the need and implement improvements to existing department procedures and processes or SOPs, where applicable.
• Train and provide guidance to junior department members in above areas as required.

Requirements

• Bachelor's degree required in a scientific discipline such as Chemistry, Biology, or Pharmacy. Graduate degree preferred.
• Minimum 7+ years' experience in the Pharmaceutical Industry.
• Minimum 5 years' previous experience in regulatory affairs.
• Minimum 3 years of regulatory experience in sterile dosage form.
• Experience with inhalation or transdermal dosage forms is a plus.
• Excellent attention to detail and organizational skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

#J-18808-Ljbffr

Piper Companies is seeking a Regulatory Affairs Specialist for an established medical device company . This role full-time/direct hire and is 100% onsite in Audubon, PA.

Responsibilities:

• Responsible for preparing and submitting regulatory documentation to the FDA for Class II and III medical devices, ensuring compliance with relevant regulations and supporting product development teams throughout the submission process.
• Collaborate with cross-functional teams to prepare and submit 510(k), IDE, and PMA documentation to the FDA.
• Review and approve regulatory documentation including labeling, drawings, and change orders for compliance.
• Maintain and update approved PMAs, including supplements and annual reports.
• Assess regulatory pathways for new or modified products and approve supporting documentation.
• Train new staff on regulatory processes and contribute to the development of SOPs.

Qualifications:

• Bachelor's degree in a health or science-related field; Engineering degree preferred.
• 2-5 years of experience in Regulatory Affairs within the medical device industry, ideally orthopedic devices.
• Strong knowledge of FDA regulatory submissions including 510(k), Pre-Sub, IDE, and PMA.
• Experience with clinical data review and regulatory impact assessments of product changes.
• Familiarity with labeling and promotional material review for regulatory compliance.
• Excellent written and verbal communication skills.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
• Strong organizational and time management skills; ability to manage multiple priorities independently and collaboratively.

Compensation:

• Salary: $80,000-$90,000 depending on experience
• Comprehensive Benefits : Medical, Dental, Vision, 401(k), PTO, vacation, and sick leave in accordance with applicable laws

This job opens for applications on 9/5/25. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

510(k), PMA, De Novo, IDE, FDA, MDR, IVDR, CE marking, EU MDR, regulatory submissions, regulatory strategy, medical devices, risk classification, technical file, design dossier, UDI, labeling compliance, regulatory compliance, quality systems, ISO 13485, ISO 14971, GHTF, regulatory documentation, health authority interactions, regulatory intelligence, regulatory audits, post-market surveillance, vigilance reporting, device registration, global regulatory affairs, regulatory pathways, regulatory operations, clinical evaluation reports (CER), biocompatibility, regulatory risk assessment, regulatory filings, SOPs, QMS, compliance audits

#LI-KS1 #LI-ONSITE

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Responsibilities:

• Summary Assist the project leads in the Regulatory Strategy & Procedure Management Practice Area in operational tasks and all aspects of technical delivery and project management.
• Primary Duties and Responsibilities
• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
• Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
• Support with VDC strategy implementation and optimization.
• Comply with and support the maintenance of internal procedures.
• Support with VDC led commercial, marketing and business development activities including proposal input and invoicing queries in close cooperation with the respective lead.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
• In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.
• The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.

Experience:

• Basic experience in area of responsibility or demonstrable capability from a similar field; ability to acquire knowledge "on-the-job".

Education

• University degree in Life Science

Skills:

• Local RA experience on the Georgian market in terms of new MAA and lifecycle management. (mandatory, around 2 years), PV and/or QA/QC experience (beneficial)
• Ability to work according to project plan and escalate potential issues according to agreed communication plan.
• Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
• Resolves routine (and some non-routine) problems in a thorough and timely manner.
• Attention to detail. High service orientation.
• Ability to prioritize and manage own time and tasks.
• Ability to convey a positive message about GCS.
• Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
• English business fluent & local language (as appropriate). Fluent in Russian (benefit).

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies
Affiliated Companies: PharmaLex GmbH

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

We are looking for a Regulatory Affairs Specialist in Georgia to join our growing team. This role is open to graduates with a Life Sciences degree and/or anyone with experience in the relevant areas.

Responsibilities:

• Assist the project leads in the Regulatory Strategy & Procedure Management Practice Area in operational tasks and all aspects of technical delivery and project management.
• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
• Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
• Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.

Experience:

• Basic experience in area of responsibility or demonstrable capability from a similar field; ability to acquire knowledge "on-the-job".

Education

• University degree in Life Science

Skills:

• Local experience on the Georgian market in terms of lifecycle management. (beneficial), Pharmacovigilance and/or Quality Assurance or Quality Control experience (beneficial)
• Ability to work according to project plan and escalate potential issues according to agreed communication plan.
• Structured way of working; limited latitude within established set of procedures, may determine priorities with general supervision.
• Resolves routine (and some non-routine) problems in a thorough and timely manner.
• Attention to detail. High service orientation.
• Ability to prioritize and manage own time and tasks.
• Ability to convey a positive message about Pharmalex
• Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise. Confident appearance.
• English business fluent & local language (as appropriate). Fluent in Russian (benefit).

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies
Affiliated Companies: PharmaLex GmbH

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Regulatory Affairs Specialist

Bridgeport CT

$100,000.00 - $125,000+ Bonus + Paid Relocation

This position will manage all regulatory affairs activities for categories in the US. This includes:

• Labeling, product development compliance, package development, SDS and ingredients statement generation, customer and regulatory compliance needs, consumer regulatory inquiries, and the safety and efficacy of ingredients.
• Partner with key stakeholders, including but not limited to Marketing, Legal and Product Development, and provide regulatory input in support of product development, ensuring regulatory requirements are communicated and elevated, where appropriate.
• Support QA and Manufacturing related to inspections, recalls and product reviews by regulatory agencies.
• Develop processes/procedures as necessary to support regulatory compliance.
• Prepare and present presentations, both written and oral, to various levels of management.
• Stay abreast of new regulatory developments and communicate relevance to the business.
• Stay abreast of advancements in toxicology research and contribute to the development of safer and more sustainable products.
• Manage workload and prioritize tasks.
• It is anticipated that this role will transfer to First Quality approximately Q4 2025.

Qualifications

• 10+ years' experience in regulatory affairs.
• Bachelors or Graduate degree in a science related field, law or regulatory science, business administration or public health preferred.
• Strong communication skills
• Ability to manage projects across various departments and teams.
• SAP experience preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams)
• Strong team player with the ability to collaborate effectively across cross-functional stakeholders

Benefits

• Health Insurance: affordable plans for medical, dental, vision and wellbeing starting on day 1
• Work-Life Balance: Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program
• Financial: 401k matching, employee share plan with voluntary investment and the company's matching shares, annual performance bonus, service awards and student loan reimbursement
• Family Support: 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships
• Career Growth: diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement