VP of Regulatory Strategy (Biopharma)

TL;DR

VP of Regulatory Strategy (Biopharma): Leading the regulatory pathway for a portfolio of in-licensed clinical-stage assets with an accent on FDA engagement, endpoint design, and de-risking development programs. Focus on orchestrating external expert networks, managing agency interactions, and ensuring regulatory intelligence informs critical go/no-go decisions.

Location: Must be based in the US or UK. The role offers remote flexibility, but candidates in the UK are encouraged to work from the London office 3 days per week.

Company

A mission-driven, VC-funded startup building a technology-first clinical trial infrastructure to accelerate the development of promising biopharma treatments.

What you will do

• Own the end-to-end regulatory strategy for the entire asset portfolio, including pathway selection and pivotal design.
• Lead direct FDA interactions (Pre-IND, IND, End-of-Phase 2, Type B/C) as the primary company representative.
• Manage external regulatory experts and KOLs to address specialist or region-specific regulatory challenges.
• Assess regulatory risk and pathway credibility during asset diligence and acquisition processes.
• Collaborate with CMC and clinical teams to ensure coherent filings and agency submissions.
• Translate complex regulatory precedents into clear strategic input for executive leadership.

Requirements

• 15+ years in regulatory affairs in biopharma, with at least 5 years in a senior strategy-owning role.
• Personally led 5+ FDA interactions as the lead voice in the room.
• Hands-on experience with multiple IND filings and at least one NDA or BLA submission.
• Experience in a small, lean, or virtual biotech environment, including asset diligence.
• Strong grasp of pathway design, endpoints, and regulatory precedents.
• Must be based in the US or UK with the ability to work in a high-growth startup environment.

Nice to have

• Experience with EMA scientific advice.
• Exposure to both small molecule and biologic modalities.
• Experience with breakthrough, fast track, or orphan designation requests.

Culture & Benefits

• Competitive salary with meaningful stock options.
• 30 days annual leave (UK) or 27 days (US) plus public holidays.
• Enhanced parental leave (16 weeks full pay for primary caregiver).
• Annual learning and development allowance (£1,000/ $2,000).
• Wellness allowance and access to gym/retail discounts.
• Regular company and team events, both virtual and in-person.

Hiring process

• Initial conversation with Head of Talent (45 mins).
• Second interview with CEO or CDO (30 mins).
• Technical/regulatory interview with the Development team (60 mins).
• Interview with Chief Medical Officer (30 mins) and a values interview (30 mins).