Director, Regulatory Affairs EU & APAC 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. 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 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 15+ years’ Regulatory Affairs experience, with a strong focus on biologics / large molecule and hands on CMC ~ Strong understanding of drug substance development, manufacturing, and regulatory submission requirements ~ Deep expertise in EU regulatory frameworks, with exposure to APAC and global markets ~ Travel required (~30%, primarily within Europe) Opportunity to shape and grow a strategic regulatory function within a commercial environment 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.
