Head of Regulatory
Head of Regulatory Affairs (Senior Director/VP) Location: San Mateo, CA (Hybrid, 3 days a week in office)
About the Company My client is a specialty biotech company with an approved rare disease product and an active Phase 3 program. The company handles regulatory strategy and writing in-house, which gives this role broad ownership and direct involvement across programs.
About the Role The Head of Regulatory Affairs will lead US regulatory strategy and serve as the main point of contact with the FDA. Reporting to the CEO and CSO, this person will guide regulatory direction for late-stage and approved programs and contribute directly to key submission documents.
Key Responsibilities
- Develop and lead US regulatory strategy for development and approved programs
- Serve as the main point of contact with FDA, including preparing for and leading agency meetings (Type A/B/C, pre-NDA)
- Write and review the main clinical and nonclinical submission sections, including CTD Modules 2.4-2.7
- Prepare FDA briefing packages, meeting requests and responses to agency questions
- Lead preparation and submission of NDAs, INDs, supplements and amendments in eCTD format
- Lead Orphan Drug Designations and other expedited pathway requests
- Work with the clinical, nonclinical, CMC and biostatistics teams to support submissions
- Keep up to date on FDA regulations, ICH guidelines and industry developments
- Maintain organized regulatory records and correspondence
Qualifications
- Advanced degree (PhD, PharmD or MSc) in a life sciences field
- 15+ years of regulatory affairs experience in biotech or pharma
- Experience leading FDA meetings and contributing to product approvals
- Hands-on experience writing clinical and nonclinical regulatory documents
- Experience with NDAs, INDs and Orphan Drug Designations
- Strong scientific writing, communication and organizational skills
- Comfortable working in a hands-on role on a small team
- Based in the Bay Area or open to relocating within California
What's Offered
- Direct reporting line to the CEO and CSO
- Broad ownership of regulatory strategy across approved and late-stage programs
- The chance to shape and build the regulatory function
- Competitive salary, bonus and benefits
If you're interested, please send me a message or email me at sydney.hewitt@epmscientific.com
All conversations are confidential.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.