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

Apply for this Regulatory Affairs Manager job online now.

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