Senior Regulatory Officer - UK Affiliates
CK Group are recruiting for a Senior Regulatory Officer to join a company in the pharmaceutical industry at their site based in Hatfield on a 12-month fixed term contract basis.
The role is based at our client's site in Hatfield which is easily commutable from the surrounding areas, with easy access from the A1(M).
The Role: The main purpose of the role will be to:
- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatchedon-time according to agreed company procedures and objectives.
- Ensure on-time submissions for all safety related changes for assigned projects.
- Liaise with 3rd parties (where required) to establish effective communication and relationships inorder to progress regulatory activities.
Further responsibilities will include:
- Liaising closely with Business Development, Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignmentin all initiatives
- Preparing regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions.
- Being actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.
To succeed in this role, you will come from a Life Science background, with previous experience working in Regulatory affairs working with marketing authorisation applications and post-approval submissions
Apply: Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Hendre Moolman on 01438 842 970 or email firstname.lastname@example.org. Please quote reference 51925.