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Associate Director Regulatory Affairs Jobs (NOW HIRING)

Nuvation Bio, Inc.

Associate Director, Regulatory Affairs

NY · On-site +1

$190K - $200K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

... regulatory affairs in the biopharmaceutical industry * Experience with drug development and commercial product regulatory requirements * Familiar with eCTD, e-publishing systems, and direct ...

BeiGene, Inc.

Associate Director, Regulatory Affairs

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Associate Director will also manage regulatory aspects of compounds through all phases of ... Preferred candidates will have experience working as a Project Lead in Regulatory Affairs, leading ...

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How much do associate director regulatory affairs jobs pay per year?

As of Aug 14, 2026, the average yearly pay for associate director regulatory affairs in the United States is $137,563.00, according to ZipRecruiter salary data. Most workers in this role earn between $110,000.00 and $174,000.00 per year, depending on experience, location, and employer.

What are the primary challenges an associate director regulatory affairs may face when managing global submissions?

One of the main challenges for an Associate Director of Regulatory Affairs is coordinating global submissions that must comply with varying regulatory requirements across different countries. This often involves managing tight timelines, staying updated on evolving regulations, and ensuring consistency in documentation. The role frequently requires cross-functional collaboration with clinical, legal, and commercial teams to gather necessary data and address country-specific concerns, making strong communication and project management skills essential for success.

What does an associate director regulatory affairs do?

An Associate Director of Regulatory Affairs oversees regulatory strategies and compliance activities for a company, typically in the pharmaceutical, biotechnology, or medical device industries. They ensure products meet all governmental regulations and standards for safety, efficacy, and labeling. This role involves leading regulatory submissions, interacting with health authorities, and guiding cross-functional teams to achieve successful product approvals. The Associate Director also stays updated on changing regulations and helps adapt company policies accordingly.

What are the key skills and qualifications needed to thrive as an associate director regulatory affairs?

To thrive as an Associate Director Regulatory Affairs, you need in-depth knowledge of regulatory guidelines, experience in regulatory submissions, and typically a degree in life sciences or a related field. Familiarity with regulatory databases, submission management systems, and relevant certifications such as RAC (Regulatory Affairs Certification) are highly valued. Exceptional leadership, strategic thinking, and strong communication skills distinguish top performers in this role. These skills ensure effective navigation of complex regulatory requirements, timely product approvals, and alignment between regulatory strategy and business objectives.
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Associate Director Regulatory Affairs jobs near you
Infographic showing various Associate Director Regulatory Affairs job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 69% Full Time, 28% Part Time, 1% Temporary, and 1% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution, with an average salary of $137,563 per year, or $66.1 per hour.

Associate Director, Regulatory Affairs - CMC

PTC Therapeutics

Warren, NJ • On-site

Full-time

Medical, Dental, Vision, Retirement

Re-posted 21 days ago

Job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Associate Director, Regulatory Affairs - CMC will be responsible for leading global regulatory CMC strategy for product development and registration, and for preparation of CMC dossier for primarily small molecule regulatory submissions (INDs and NDAs) according to global regulatory expectations and requirements.
This position works cross-functionally with Regulatory Affairs, Technical Operations, and Quality to facilitate the completion of regulatory filing documentation in accordance with company timelines.
This position ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Job Description:
Responsibilities:
  • Leads and manages the development and preparation of CMC-related submission documents for small molecule products in collaboration with Technical Operations, Quality, and Regulatory Affairs to ensure they are organized, logical, and meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but not limited to, new drug marketing applications (eg NDA, MAA, NDS, etc), electronic Common Technical Documents (eCTDs), investigational new drug applications (eg INDs, CTAs), briefing documents, response to queries, Orphan Drug Applications, and annual reports.
  • Leads global post-approval CMC regulatory strategy for commercial products, providing CMC regulatory leadership for lifecycle changes (e.g., manufacturing site changes, scale-up/tech transfer, process improvements, control strategy updates, and analytical method changes) to ensure supply continuity and align data packages to regional requirements.
  • Collaborates with Regulatory Affairs Team to develop robust global regulatory CMC strategy and risk mitigation to enable successful regulatory submissions and approvals for drug development and registration.
  • Manage or assist with regulatory agency interactions.
  • Effectively interprets and applies regulatory guidance. Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.
  • Works with CMC Writing, Regulatory Operations, and Submission Project management to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review, and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
  • Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
  • Remains current on CMC regulatory intelligence including guidelines and compendial requirements

Qualifications:
Bachelor's degree in scientific discipline. A minimum of 7-8 years Regulatory Affairs experience and/or CMC technical writing experience in a pharmaceutical, biotechnology or related environment. Advanced degree a plus.
  • Technical knowledge in small molecules with experience in translating to a regulatory document
  • Demonstrated, hands-on experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.
  • Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Excellent working knowledge of the ICH region regulations for small molecule drugs.
  • Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy.
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, NDS, briefing documents, and response to agency queries.
  • Ability to influence without direct authority.
  • Demonstrated excellent collaboration skills.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  • Proficiency with Microsoft Office.
  • Advance academic degree (Masters or PhD).
  • Regulatory experience in non-CMC related matters.
  • Regulatory experience in supporting development and registration in ex-ICH regions

Travel requirements- Up to 10% travel
Expected Base Salary Range:
$169,100 - $212,800. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.
In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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