Senior Director Regulatory Affairs

Meet Life Sciences; San Francisco (CA); On-site; USD 260,000 - 360,000; Full time

Job summary

Meet Life Sciences is seeking a Senior Director, Regulatory Affairs to shape and execute global regulatory strategy across a growing clinical pipeline. This role offers direct FDA interaction, leadership in development strategy, and ownership of regulatory plans from IND/CTA through late-stage submissions.

The successful candidate will lead FDA interactions and steer cross-functional teams across CMC, Clinical Development, and Quality, building regulatory infrastructure as the organization

Qualifications

• 12+ years of biopharmaceutical industry experience.
• 8+ years in Regulatory Affairs with FDA leadership.
• Experience guiding global regulatory strategies from IND to NDA/BLA/MAA.
• Direct involvement in NDA, BLA or MAA submissions.

Responsibilities

• Develop and execute global regulatory strategies for assigned programs.
• Lead FDA interactions and agency meetings (pre-IND, End-of-Phase 2, Type B/C, pre-NDA/BLA).
• Provide regulatory input into integrated development plans and protocols.
• Identify opportunities for expedited pathways and designations.
• Oversee regulatory planning across INDs, CTAs, amendments, DSURs, designation requests.
• Coordinate regulatory interactions with international health authorities.
• Represent Regulatory Affairs on cross-functional teams and brief executives.
• Help build regulatory infrastructure as the pipeline grows.

Skills

Regulatory strategy

FDA interactions

Cross-functional leadership

Job description

We are partnering with a clinical-stage biotechnology company to appoint a Senior Director, Regulatory Affairs who will take a leading role in shaping and executing global regulatory strategy across a growing clinical pipeline.

This is a highly visible opportunity for an experienced regulatory leader who wants genuine program ownership, direct FDA interaction, and the ability to influence development strategy within a lean, fast-moving and science-driven biotech environment.

The Opportunity

As Senior Director, Regulatory Affairs, you will own regulatory strategy for one or more clinical-stage programs, supporting development from IND/CTA through late-stage development and preparation for potential marketing applications.

You will serve as a primary interface with the FDA and partner closely across Clinical Development, Clinical Operations, CMC, Nonclinical and Quality.

Importantly, this is not simply a submissions-focused position. You will have a meaningful voice in development strategy, protocol design, endpoint selection, evidence generation and regulatory pathway planning.

Key Responsibilities

• Develop and execute global regulatory strategies for assigned clinical-stage programs.
• Lead FDA interactions and formal agency meetings, including pre-IND, End-of-Phase 2, Type B/C and pre-NDA/BLA meetings.
• Provide strategic regulatory input into integrated development plans, clinical protocols and evidence-generation strategies.
• Identify and pursue opportunities for expedited regulatory pathways and designations.
• Lead regulatory planning and oversight across INDs, CTAs, amendments, DSURs and designation requests, while driving future NDA/BLA/MAA readiness.
• Coordinate regulatory interactions with international health authorities.
• Represent Regulatory Affairs on cross-functional program teams and communicate regulatory strategy, risks and recommendations to executive leadership.
• Help build regulatory infrastructure and capabilities as the organization and pipeline grow.

What We're Looking For

We're looking for an established regulatory professional with significant experience guiding clinical development programs and working directly with the FDA.

You will ideally bring 12+ years of biopharmaceutical industry experience, including 8+ years within Regulatory Affairs, with demonstrated success leading FDA interactions and formal agency meetings.

Strong experience developing global regulatory strategies, working across IND through NDA/BLA stages, and influencing cross-functional development teams will be important.

Experience within a clinical-stage or emerging biotech is particularly attractive, as is experience with expedited regulatory pathways and direct involvement in an NDA, BLA or MAA submission.