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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.

Senior Manager / Associate Director, Regulatory Affairs

Neurona Therapeutics

South San Francisco, CA • On-site

$140 - $210/hr

Other

Posted 6 days ago

Job description

We are hiring! Our ideal candidates are self-motivated individuals who have clearly demonstrated a passion for scientific research. This is a fantastic opportunity to join a small team, work on transformative science, and build an exciting, science-driven company. Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.

Position: Senior Manager / Associate Director, Regulatory Affairs

Location:

South San Francisco, CA

Job Id:

357

# of Openings:

1

Senior Manager / Associate Director, Regulatory Affairs

Neurona Therapeutics is seeking a highly motivated Regulatory Affairs professional to join our growing team. This role spans both Clinical and CMC (Chemistry, Manufacturing, and Controls) regulatory affairs, and the ideal candidate brings a strong scientific background along with the ability to navigate the complex regulatory landscape for advanced therapy medicinal products (ATMPs) — specifically cell therapies. This position reports to the Head of Regulatory Affairs and plays a critical role in advancing our clinical programs toward market approval.

Key Responsibilities:
  • Serve as a regulatory strategist and subject matter expert, advising clinical, CMC, and technical teams on regulatory requirements and pathways throughout development
  • Author, review, and manage the preparation of high-quality regulatory submissions, including INDs, CTAs, meeting requests, briefing packages, and ultimately BLAs/MAAs
  • Conduct regulatory risk assessments and develop proactive mitigation strategies to keep programs on track
  • Lead or support health authority interactions, including managing timely, high-quality responses to health authority queries and information requests
  • Develop and maintain regulatory submission strategies and timelines in partnership with Clinical, CMC, Quality, and Nonclinical teams
  • Ensure regulatory compliance is maintained across the product lifecycle, partnering with internal and external stakeholders (e.g., CROs, CDMOs, regulatory consultants)
  • Monitor and interpret evolving regulatory guidance and precedent relevant to cell therapies, with particular attention to the epilepsy and broader CNS space
  • Contribute to the development of departmental processes, templates, and best practices as the regulatory function scales
  • Mentor and, over time, manage junior regulatory staff as the department grows
Education:
  • PhD in Neuroscience, Cell Biology, Biochemistry, or a related scientific field is required (or equivalent experience with an advanced degree)
Experience:
  • Senior Manager: 4+ years of direct regulatory affairs experience in the biotechnology industry
  • Associate Director: 6+ years of direct regulatory affairs experience, with a track record of increasing scope and responsibility
  • Hands‑on experience with cell and/or gene therapies strongly preferred
  • Experience with CNS products, particularly epilepsy, is a significant advantage
  • Demonstrated success authoring and submitting major regulatory filings (e.g., IND, CTA, BLA, MAA) and leading or supporting health authority interactions
Knowledge and Skills:
  • Deep understanding of US FDA (CBER) and EU EMA regulatory requirements, guidelines, and processes; experience with other regions (e.g., Health Canada, MHRA, PMDA) is a plus
  • Strong working knowledge of GMP, GCP, and GLP regulations
  • Excellent scientific writing, editing, and verbal communication skills, with the ability to distill and present complex issues clearly and persuasively to varied audiences
  • Proactive and self‑directed, with the ability to manage multiple priorities and shifting deadlines in a fast‑paced, matrixed environment
  • Strong interpersonal and cross‑functional collaboration skills
  • Proficiency in Microsoft Office applications; experience with regulatory information management (RIM) systems or electronic submission tools a plus

Neurona Therapeutics
490 Forbes Blvd, Suite 600
South San Francisco, CA 94080
info@neuronatx.com

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