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 email@example.com.