Skills Alliance
Senior Vice President Regulatory Affairs
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SVP Regulatory Affairs / Chief Regulatory Affairs Officer
Location: UK, Germany or United States
Confidential search | Late-stage biotechnology
The opportunity
A late-stage biotechnology company developing novel oral therapies for neurological and autoimmune diseases is seeking an accomplished regulatory executive to lead its global regulatory strategy.
With a lead programme in pivotal Phase 3 development and additional clinical and preclinical assets, the company is approaching a significant transition towards registration and potential commercialisation. This leader will shape the path from pivotal data to submission and approval, while guiding regulatory development across the broader pipeline.
The appointment may be made at SVP Regulatory Affairs or Chief Regulatory Affairs Officer level, depending on experience and agreed scope.
Key responsibilities
- Own global regulatory strategy, with immediate emphasis on US registration and a clear European development and approval pathway.
- Lead NDA preparation and submission readiness, aligning clinical, statistical, nonclinical, safety and CMC contributions into a compelling regulatory dossier.
- Serve as the senior regulatory representative with FDA, EMA and other relevant health authorities, leading scientific advice, milestone meetings and submission discussions.
- Guide regulatory strategy for additional indications and pivotal programmes, including trial design, endpoints and evidence requirements.
- Anticipate regulatory risks and translate complex development questions into clear recommendations for executive leadership.
- Partner closely with Clinical Development, Biostatistics, Medical Safety, CMC, Quality and Commercial to support an integrated route to approval.
- Build and lead a proportionate regulatory function, combining internal expertise with specialist external support.
- Oversee submission quality, regulatory operations, labelling strategy and responses to health authority questions.
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Candidate profile
- Extensive regulatory affairs experience, including senior leadership within biotechnology or pharmaceutical organisations.
- Direct ownership of an NDA or MAA through submission, review and approval, with substantial FDA engagement.
- Strong expertise in late-stage clinical development and registration strategy; neurology or multiple sclerosis experience is highly desirable.
- Experience with oral small-molecule therapies and the integration of clinical, nonclinical and CMC requirements.
- Proven ability to lead complex health authority negotiations and resolve challenging regulatory questions.
- Comfortable operating strategically while remaining closely involved in submission execution within a lean biotechnology environment.
- Track record of building teams, managing external partners and influencing decisions across executive and development functions.
- Advanced qualification in a relevant scientific, medical or pharmaceutical discipline preferred.
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Why join?
An opportunity to take ownership of the regulatory agenda at a pivotal stage of development, influence the route to potential first approval and establish the foundations for a broader neurological and autoimmune portfolio.
Candidates based in the UK, Germany or United States will be considered, with international travel anticipated.
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