Director, Regulatory Affairs
Core
Lead regulatory operations activities across APAC, focusing on Health Authority submissions and operational delivery for biotechnology and pharmaceutical clients.
Role type
Senior leadership regulatory operations director
Builds
Regulatory submissions and strategies for clinical development programs
Domain
Biotechnology / Pharmaceuticals / Contract Research Organisation (CRO)
Deliverable
client delivery
Required skills
Strategic planning, team leadership, resource management, regulatory submission planning, eCTD lifecycle management, Health Authority meeting preparation, SOP development, budgeting, audit support
Preferred skills
Knowledge of Chinese regulatory pathways, Mandarin language capability, experience with TFDA/MFDS/HSA/NPRA submissions
Technologies
SharePoint, Adobe, project-management tools, eQMS, Salesforce, eTMF platforms
Responsibilities
Lead and mentor the APAC Regulatory Operations team; oversee APAC Health Authority submissions (TGA, Medsafe, MFDS, TFDA, FDA); develop global regulatory strategies; prepare for Health Authority meetings; drive process improvement via SOPs; provide input on proposals and budgets; support internal and external audits
Seniority
Director, strategic leadership