Senior Associate, ESOQ Regulatory Operations
Core
Support post-approval changes, initial registrations, renewals, and regulatory compliance assessments for pharmaceutical products.
Role type
Senior Associate Regulatory Operations (GXP/Quality Assurance)
Builds
Regulatory dossiers, change management records, and compliance reports for commercial drug and medical devices.
Domain
Pharmaceutical industry, Regulatory Affairs, Quality Assurance (GMP/cGMP)
Required skills
Change management, Regulatory affairs, GMP/cGMP compliance, Quality assurance, eQMS/QTS modules, US/European/global regulatory guidelines, Risk-based approach, Technical writing, Project leadership
Preferred skills
Supplier quality management, Cross-functional collaboration, AI tools (generative AI), Adaptability to fast-paced environments
Technologies
eQMS, QTS, SAP (Material Master)
Responsibilities
Support post-approval changes and initial registrations, Perform regulatory impact assessments, Coordinate document collection for regulatory submissions, Act as liaison between CMOs and internal functions, Support investigations into regulatory discrepancies, Manage complaints for drug and medical devices, Review and approve SAP material master workflows
Seniority
Senior, hands-on IC
