Job Description

We are partnering with a well established Biotech company here in the SF Bay Area as they search for their next Associate Director of Regulatory Affairs. The ideal candidate with have in depth expertise in Oncology/Autoimmune Diseases. Candidates with large molecule experience are HIGHLY preferred.

Please note, you must reside in the Bay Area to be considered.

Key Responsibilities:

• Provide strategic regulatory and scientific leadership to cross-functional development teams, ensuring programs are well-positioned for regulatory success and scientific differentiation.
• Oversee the planning, preparation, and submission of regulatory documents to global health authorities (e.g., FDA, EMA), including INDs, CTAs, DMFs, BLAs, and MAAs.
• Drive regulatory strategy to support clinical trial execution, marketing approval, and lifecycle management of regulatory applications.
• Ensure all submissions meet quality standards, align with corporate objectives, and comply with evolving global regulations.
• Lead the development of critical documents such as the Target Product Profile (TPP), core data sheets, product labeling, and promotional review.
• Act as the primary liaison with regulatory authorities; lead meeting strategy, execution, and follow-up communications.
• Coordinate the creation of briefing packages, address regulatory queries, and guide teams on risk assessment and mitigation approaches.
• Partner with regulatory operations to build and maintain submission timelines and global regulatory plans.
• Track and interpret regulatory trends and competitive intelligence to inform internal strategy and maintain compliance.

Preferred Qualifications:

• Bachelors degree in Life or Health Sciences required; advanced degree (MS, PhD, PharmD) strongly preferred.
• 810 years of industry experience in pharmaceuticals or biotechnology, with a minimum of 46 years in regulatory affairs.
• Demonstrated experience leading global regulatory submissions and interactions with major health authorities.
• Deep knowledge of U.S. and international regulatory frameworks; experience with expedited pathways
• Proven ability to interpret complex scientific data to inform strategic decision-making.
• Exceptional communication and leadership skills, with a track record of building consensus and driving alignment across functions.
• Proficient in leading cross-functional teams and external stakeholders toward shared goals in a matrixed environment.
• Experience managing regulatory agency engagements such as FDA Type B/C meetings, EMA Scientific Advice, Advisory Committees, or Oral Explanations is highly desirable.

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