VP Regulatory Strategy
New
L
Lindus HealthBiopharma
US; Secondary Locations: UKFull-TimeVp
Salary not disclosed
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Job Details
- Experience
- 15+ years
Requirements
- 15+ years in regulatory affairs in biopharma.
- At least 5 years in a senior strategy-owning role (e.g., Senior Director, VP, Head of Regulatory Affairs).
- Personally led 5+ FDA interactions (pre-IND, End-of-Phase 2, Type B/C) as the lead voice.
- Hands-on ownership of multiple IND filings and maintenance.
- Involvement in at least one NDA or BLA as lead or core contributor.
- Experience with breakthrough, fast track, or orphan designation requests.
- Strong grasp of pathway design, endpoints, and regulatory precedents.
- Ability to work in a small, lean, or virtual biotech environment.
- Experience with asset in-licensing or acquisition diligence.
- Strong strategy setting for programs across multiple therapeutic areas and modalities.
Responsibilities
- Set and own the regulatory strategy across the portfolio, including pathway selection and pivotal design implications.
- Lead FDA interactions directly (Pre-IND, IND approval, End-of-Phase 2, Type B/C) as the lead spokesperson.
- Manage external regulatory experts and KOLs for specialist or region-specific questions.
- Coordinate with CMC and clinical colleagues to ensure coherence across functions.
- Assess regulatory risk and pathway credibility during asset diligence.
- Pressure-test clinical development plans against likely agency positions.
- Build the regulatory intelligence that informs exit conversations.
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