Accenian are currently working with a Global Pharmaceutical company who are seeking a Head of Regulatory Submissions in the UK.
The role entails:
- Provide leadership to the EU central regulatory affairs submissions team. Obtain and maintain marketing authorisations for products in EU and non-EU territories.
- Ensure on time launches, supply and compliance of all products.
- Support and work closely with the Head of Regulatory Affairs EU.
- Lead and track key products to ensure milestones are achieved and on time and be accountable for the EU submissions team. Provide regulatory status of key products through development, submission, approval and post approval.
- Represent team on key project meetings and provide regulatory guidance and decisions and outcomes.
- Drive submission quality by promoting and facilitating active feedback to the regulatory science teams.
You must:
- Have a scientific degree
- Proven experience and tenures working in pharma regulatory affairs for established products.
- Recent experience in managing and leading EU submissions.
- Experience of managing a team.
If you are interested in applying for this role then please send your CV to [email protected]