Associate Director Regulatory Compliance
Core
Lead the Regulatory Compliance team across EU locations (Ireland, UK, Berlin) to ensure safe work practices, manage product release, and oversee clinical supply chain compliance.
Role type
Senior IC regulatory compliance leader (Qualified Person)
Builds
Clinical supply chains and product release processes
Domain
Biopharma / Sterile manufacturing / ATMP
Required skills
Sterile/ATMP expertise, EU GMP/HPRA/FDA knowledge, Qualified Person (QP) certification, team leadership, budget management, supplier audit coordination, risk register oversight, SOP development
Preferred skills
None stated
Technologies
Master Control system
Responsibilities
Lead implementation of right first time QP release, maintain oversight of regulatory change, act as main point of contact for Tier 3 escalations, develop and monitor annual budget, certify QP for batch review and release, manage CMO audits and quality technical agreements, review deviations and non-conformance reports, generate SOPs and work instructions, coordinate QP Supply chain Management Programme
Seniority
Senior, hands-on IC
