Director, Regulatory Affairs EU
Blackfield Associates are exclusively supporting the opportunity for a Regulatory Affairs Director to lead and expand EU regulatory capability within a global CDMO environment, with a strong focus on large molecule drug substances and Biologic products.
This role sits at the intersection of client delivery, regulatory compliance, and commercial growth, acting as a key partner to both internal teams and external clients. You will play a central role in strengthening regulatory operations, enhancing service offerings, and supporting the successful development and manufacture of biologics across international markets.
Key Responsibilities:
- Provide matrix leadership across multiple EU & APAC manufacturing sites (large molecule focus)
- Partner with site leadership to build and develop regulatory capability aligned to client delivery needs
- Support hiring, onboarding, and mentoring of regulatory teams within a multi‑site CDMO environment
- Act as a senior regulatory contact for CDMO clients, supporting development and commercial programmes
- Provide strategic regulatory guidance across drug substance (CMC) development, manufacturing, and lifecycle activities
- Support key client programs including tech transfers, scale‑up, and global expansion initiatives
- Ensure high‑quality, on‑time regulatory deliverables aligned with client expectations
- Support commercial activities including regulatory input into proposals, quotations, and new business opportunities
- Oversee site compliance including licenses, SMF/DMF, regulatory documentation, and audit readiness
- Support quality event resolution and regulatory risk mitigation in collaboration with QA and site leadership
- Monitor and interpret changes in global regulatory requirements (EMA, FDA, ICH) with relevance to biologics manufacturing
- Provide internal SME support on regulatory strategy for CDMO clients and products
- Drive knowledge‑sharing and capability building across the regulatory network
Experience & Qualifications:
- Advanced degree in Life Sciences (Pharmacy, Biology, Chemistry, etc.)
- 15+ years’ Regulatory Affairs experience, with a strong focus on biologics / large molecule CMC
- Proven experience in a CDMO or external partnering environment (Essential)
- Strong understanding of drug substance development, manufacturing, and regulatory submission requirements
- Deep expertise in EU regulatory frameworks, with exposure to APAC and global markets
- Demonstrated experience working with clients and managing external stakeholder relationships
- Proven leadership experience in matrix and multi‑site environments
Additional Information:
- Travel required (~30%, primarily within Europe)
- Exposure to global CDMO operations and high‑impact client programmes
- Opportunity to shape and grow a strategic regulatory function within a commercial environment
- Excellent stakeholder management across clients, regulators, and internal teams
- Ability to operate in a fast‑paced, client‑driven CDMO environment
- Strong communication, negotiation, and influencing skills
- Fluent English (additional languages advantageous)
This is a full time, permanent role. Remote based in the UK. Due to the matrix requirements of the role, applicants from a predominately perm background only being considered- not suitable for contractor/ consultants.
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