Regulatory Affairs Executive/ Manager
Core
Manage drug product registrations and ensure ongoing regulatory compliance across relevant markets for a pharmaceutical company.
Role type
Regulatory Affairs Specialist / Manager
Builds
Drug product registrations and regulatory compliance
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
CTD/eCTD dossier compilation, HSA drug registration requirements, regional pharmaceutical regulatory frameworks, drug labelling and packaging review, pharmacovigilance documentation, regulatory strategy, team leadership
Preferred skills
Electronic submission platforms (e.g. PRISM), regulatory databases
Responsibilities
Prepare and submit CTD/ACTD-format regulatory dossiers, ensure product compliance with guidelines (GMP, pharmacovigilance, labelling), liaise with health authorities on submissions and approvals, review drug labelling and promotional materials, monitor regulatory changes, collaborate with R&D and commercial teams, support adverse event reporting, maintain regulatory documentation, lead junior staff and manage external consultants
Seniority
Specialist (Mid-level) / Manager (Senior, hands-on IC with mentorship)
