Senior Regulatory Affairs Consultant

Freelance Senior Regulatory Affairs Consultant | 12-Month Contract | Remote (Europe)

About the Opportunity
A rapidly growing late-stage biotechnology company is seeking an experienced Senior Regulatory Affairs Consultant to support its expanding global development portfolio as it prepares for major regulatory submissions and commercialisation activities.

With a lead biologic entering a critical regulatory phase following positive Phase 3 data, this consultant will play a key role in driving global regulatory strategy, coordinating major submissions, and supporting interactions with international health authorities.

Key Responsibilities
- Lead regulatory strategy for late-stage biologics programmes across the US and Europe.
- Support preparation and execution of BLA, MAA, and other global marketing applications.
- Coordinate regulatory activities across Clinical Development, CMC, Quality, Pharmacovigilance and Medical Writing.
- Prepare briefing documents for FDA, EMA and other global health authority interactions.
- Provide strategic input into lifecycle management and indication expansion plans.
- Review CTD documentation and ensure submission readiness.
- Assess regulatory risks and recommend mitigation strategies.
- Support responses to health authority questions throughout the review process.


What we are looking for
- 8+ years' experience within Regulatory Affairs in biotech, pharmaceutical or consultancy environments.
- Demonstrated experience supporting late-stage biologics development.
- Experience preparing or leading BLA, MAA, or major global submissions.
- Strong knowledge of FDA, EMA and ICH regulatory requirements.
- Previous experience supporting health authority meetings and regulatory negotiations.
- Excellent stakeholder management and project leadership skills.