Senior Regulatory Affairs Officer required for top 5 pharmaceutical company based in Surrey, UK.
Our client, a top 5 pharmaceutical company, are currently recruiting for a Senior Regulatory Affairs Officer to join their team based at their impressive stately home premises (complete with tennis courts), based in Surrey. As the Senior Regulatory Affairs officer you will be responsible for operational and strategic issues within the regulatory affairs function on a European basis.
This Regulatory Affairs role will include:
- Leading submissions and approval of a wide range of EU regulatory submissions including line extensions with direct management support
- Representing the Regulatory Affairs team on one or more product development teams including those in late stage development
- Supporting a senior scientist on a key project
- Consult internal staff as necessary to formulate European position on tactical and strategic issues
- Provide solicited and unsolicited advice to product team members to ensure appropriate labeling, regulatory strategy, environmental influences are taken into consideration for a timely, high quality EU dossier to be compiled
- Maintain licences after approval, including fulfillment of commitments
- Support clinical trial applications in European countries
The successful candidate will have a comprehensive understanding and knowledge of European regulations as well as an understanding of the cross-functional nature of drug development and regulatory implications and challenges. The following skills and competencies are also essential for the role:
1. Influence/Interpersonal skills:
• Ability to positively impact colleagues and teams
• Assembles external resources to resolve regulatory issues as appropriate
2. Self Management:
• Ability to work independently and in teams
• Demonstrate use of initiative and proactivity
• Time management skills
• Proven ability to write, present and, listen effectively
• Problem solving and negotiation skills
This is a fantastic opportunity for a talented individual to progress their career within Regulatory Affairs with a leading pharmaceutical company, who are dedicated to the training and development of their staff.
If you would like to hear more about this role, please contact Jonathan Hart-Smith on 01438 743047 or email email@example.com.
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