Regulatory Affairs Officer Iberia – Barcelona

Under the direction of the Regulatory Lead Iberia, compile, elaborate and revise all documentation to submit the Marketing Authorization Applications (MAAs), Marketing Authorization (MA) variations and renewals to the Health Authorities, in accordance with the Ipsen procedures and local legislation. Management of packaging materials for medicines.

Review promotional activities of the products in charge of generated by the marketing & medical department in accordance with the Local Regulation, Code of Conduct and Ipsen policies.

Responsibilities

• Compile, elaborate, and revise all documentation for MAAs and related submissions.
• Manage packaging materials for medicines.
• Review promotional activities and ensure compliance with regulations and company policies.

Requirements – Essential

• Experience in a similar position with proven experience in Regulatory Aff...