Regulatory Affairs Manager – Post market / Product lifecycle based in North, Mid Wales, UK

Regulatory Affairs Manager – Post market / Product lifecycle based in North, Mid Wales, UK

Our client, a leading pharmaceuticals company, is currently looking for a Regulatory Affairs Manager to join their team. Reporting to the Director of Post Marketing Regulatory Affairs, you will be responsible for three or more people, taking responsibility for training, work-flow and answering work –related questions.

Further responsibilities of this Regulatory Affairs Manager job include:

  • Providing guidance, supervision and leadership of subordinates in local regulatory staff.
  • Managing the preparation of regulatory dossiers/submissions for assigned projects and ensure these comply with regulatory policies.
  • Reviewing regulatory documents for accuracy and soundness before submissions are filed.
  • Reviewing pending regulations and prepare critiques for submission to the authorities.
  • As required, reviewing and approving new and modified company documents such as SOPs, clinical protocols and labelling.
  • Ensuring full compliance with the relevant regulatory authorities.

The successful candidate will have working knowledge of applicable FDA/international regulations and cGMP, along with a strong technical knowledge of OCD products, processes and equivalent. The following competencies are also essential for this Regulatory Affairs Manager role:

  • Excellent communication and negotiation skills. .
  • Ability to multitask and prioritise work load.
  • Be able to work efficiently in cross functional teams.
  • Ability to work independently.
  • Build and maintain working relationships with regulatory staff.

If you would like to hear more about this opportunity, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Apply for this Regulatory Affairs Manager job online now.

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