Senior Regulatory Officer (EU Central) - 6-month contract

CK Group are recruiting for a Senior Regulatory Officer (EU Central) contractor to join a company in the pharmaceutical industry at their site based in Hatfield on a 6-month contract basis.

The role is based at our client's site in Hatfield whichis 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 anddispatched 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

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 hmoolman@ckgroup.co.uk. Please quote reference 51927.