The Role: To provide RA leadership on product lifecycle management (change management) and global product registrations. Provide support for initiating and tracking impact assessments for...
Submitting Marketing Authorisation applications of CP/DCP/MRP/National procedures & relevant activities across international markets including, UK, IE, EU, MENA and CIS regions.
Review / Audit of dossiers for marketing authorizations;
Monitoring of the registration process (CP/DCP/MRP/National procedures)
Preparation/Verification of responses / variations documentation / notifications for CP/DCP/MRP/National procedures;
Submission of End of Procedure national phase documents for DCP/MRP procedures;
Obtaining MAA Renewals/Notifications;
Correspondence with regulatory authorities & other relevant agencies;
Maintaining files for product licenses;
Co-ordinating and submitting the new applications and post approval changes.
To offer assistance in compilation of dossier before submission to the agencies and to handle the validation phase and country specific requirements for the procedures with the aim of quick validation and procedure start.
To be a part of team and assist in documentation, archiving and communication to multiple departments the receipt of MA and variation details to ensure effective change implementation and compliance.
Life Science Degree qualified
Extensive proven Regulatory experience with strong commercial awareness ideally in a Pharmaceutical/Manufacturing or a similar environment -maintaining post marketing maintenance.
Writing of CMC (module 2 and 3), Variations (Type 1A, Type 1B) and renewals
Experience of working with line management in the business with ability to influence, challenge and deliver change.
Ability to build relationships with people of all levels in the organisation and to use these relationships to deliver exceptional results.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.