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 main purpose of the role will be to:
- Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-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 in order 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 alignment in 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.
Entitlement to work in the UK is essential. Please quote reference 51925.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Contact: Hendre Moolman
- Phone: 01438 743 047
- Reference: 51925
Website: CK Group
- Posted: 14th October 2021
- Expires: 11th November 2021