Regulatory Affairs Manager
Core
Manage regulatory filings for new medicine applications and maintenance of existing product registrations with authorities.
Role type
Regulatory Affairs Manager
Builds
Regulatory submissions and product registrations
Domain
Pharmaceutical industry
Required skills
Pharmaceutical Regulatory Affairs, Regulatory Compliance, Regulatory Strategy Development, Process Improvements, Collaboration, Communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Prepare plans and set up processes for filing new medicine applications and maintaining registration of existing products; Notify regulatory authorities of changes to medicines; Maintain processes for updating labels based on global requirements; Assist in monitoring the Pharmacovigilance (PV) system; Assist in product quality control with the Supply Chain Management (SCM) team; Obtain regulatory approval within optimum timelines to ensure new products are made accessible quickly; Develop and implement time and cost-saving initiatives.
Seniority
Mid-level (3+ years experience required)