Associate Director Regulatory Affairs - Hybrid - San Diego
We are partnering with a clinical stage biopharma who are focused on developing innovative small molecule therapies across rare endocrine and autoimmune diseases. With programs progressing through Phase 2 development, the company is entering a pivotal stage of growth and is seeking an Associate Director of Regulatory Affairs to support the advancement of multiple development programs toward later-stage clinical development and eventual registration.
Reporting directly to the VP of Regulatory Affairs, this individual will play a key role in developing and executing global regulatory strategy across the portfolio, supporting interactions with FDA and other global health authorities, and helping guide programs from early development through potential NDA enabling activities.
This is an opportunity to join a highly collaborative biotech environment where Regulatory Affairs operates as a strategic partner across the organisation and maintains significant visibility with executive leadership.
Key Responsibilities
- Support the development and execution of global regulatory strategies for assigned development programs across rare endocrine and autoimmune indications
- Provide regulatory leadership for products progressing through Phase 2 clinical development, supporting longer-term pathways toward NDA and global registration
- Lead and coordinate regulatory activities related to:
- INDs, CTAs and ODD Applications
- FDA meeting preparation and briefing documents
- Annual reports and lifecycle management activities
- Support regulatory interactions with FDA and other global health authorities, including meeting strategy, briefing package development, and response coordination
- Collaborate cross functionally with Clinical Development, Clinical Operations, CMC, Nonclinical, Biometrics, Medical Writing, and Quality teams to align regulatory strategy with overall development objectives
- Provide regulatory input into clinical protocols, study design, endpoint strategy, and development plans
- Support preparation for future NDA-enabling activities and long-term global regulatory planning
- Ensure submissions comply with applicable FDA and ICH regulatory requirements and guidance
- Monitor evolving regulatory guidance and competitive regulatory landscape within endocrinology, autoimmune, and rare disease therapeutics
- Manage relationships with external vendors, consultants, and publishing partners as needed
Qualifications
- Bachelor’s degree required, advanced scientific degree (MS, PharmD, PhD) preferred
- 7+ years of Regulatory Affairs experience within biotech and/or pharmaceutical industry
- Experience supporting regulatory strategy and submissions across clinical-stage development programs
- Strong understanding of FDA regulatory pathways, IND lifecycle management, and global drug development processes
- Prior experience supporting FDA meetings and major regulatory submissions
- Small molecule development in a Regulatory affairs setting is a must
- Endocrinology, and/or autoimmune therapeutic area experience highly desirable, but open to other tx areas with Rare Disease experience
- Familiarity with NDA preparation and late stage development strategy is a plus
- Strong communication, collaboration, and stakeholder management skills