Regulatory Affairs Manager

Job Opportunity : Regulatory Affairs Manager

We are seeking a skilled Regulatory Affairs Manager to join our team. This role involves managing the registration of medicinal products through European procedures (MRP, DCP, CP) or national submissions across all regions of interest.

Main Responsibilities :

• Developing and implementing submission strategies for each project, in line with all applicable requirements, and assigning due dates
• Coordinating the preparation of document packages for regulatory submissions, in line with the in force European regulations and / or local pharmaceutical laws depending on the submission type and market
• Ensuring that all responses to authorities' requests are correct, complete, and timely provided
• Communicating with third parties to expedite submissions and ensure regulatory compliance
• Managing additional processes related to national submissions (pre-reviews, DMF, PMF, GMP accreditation etc.) to ensure timely completion and avoid delays
• Providing accurate and complete information to other departments / third parties in a timely manner
• Supporting samples preparation and dispatch when necessary
• Informing relevant functions on the status and progress of assigned projects to meet set objectives, identify potential problems or delays, and possible solutions as they occur
• Compiling, verifying, and publishing submissions using electronic publishing software considering submission deadlines and technical requirements for management of dossiers lifecycle
• Documenting and tracking regulatory-related processes within the organisation
• Maintaining internal trackers and dedicated templates up-to-date
• Performing regular reviews of information available on the internal SP

Candidate Requirements :

Benefits :