Summary:
-Support the management of regulatory approvals and registration activities
-Ensure that regulatory compliance is maintained for products. Acts within country policies and practices to reduce company exposure to regulatory, quality and liability risks.
-Work closely with manager to maintain contact with the Regulatory Authorities pertaining to all regulatory matters.
Responsibilities :
-Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
-Prepare, review, and approve labeling and SOP's
-Participate as an active team member and provide regulatory advice to project teams as required
-Respond to regulatory authorities questions with strict deadlines
-Maintain regulatory files in a format consistent with requirements
-Develop regulatory project plans
-Support regulatory activities relating to specific portfolio of products/projects (product owner)
-Maintain and update existing regulatory authorizations
-Represent or lead Regulatory Affairs in small project teams
-May review promotional material for compliance with local regulations
Experience :
-Bachelor's degree or country equivalent in pharmacy or related scientific discipline. Higher degree/PhD will be an advantage.
-2 Years of Regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization.