Description
Role: Regulatory Affairs ManagerLocation: Hertfordshire
Salary: Circa £65,000
I am looking for someone who has spent most of their career in Regulatory Affairs, approximately 9+ years and hoping they are now looking for a new challenge to step into a very senior position looking after a lifesaving drug. The company's mission is to continue provide a competitive supply of great plasma derived products to global markets, simply to help support health experts around the globe.
Description:
- Develop robust product licensing strategies for new products and new markets.
- Manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries.
- Obtain Marketing Authorisations in the US, Europe countries, European Union (EU) or Intercontinental markets for designated products and manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.
- Maintain existing licences (commitments, variations, renewals).
- Communicate directly with the relevant departments on the generation of any regulatory documents.
- Recommend contacting and communicate directly with health authorities about seeking advice, guidance or clarification of legal issues, dossier content or submission procedural matters. Active participation in meetings with FDA and EMA.
- Generate or supervise the generation of regulatory dossiers in eCTD format.
- Actively maintain RA data bases, documentation and procedures to ensure regulatory compliance of BPL products released to market.
If this is something you would consider then please do give me a call on , alternatively email me on L.khan(a)realstaffing.com - should you have any referrals
I am more than happy to have a chat with you regarding them as you will also be given incentives for a successful candidate.
Latifah Khan
Regulatory Affairs Specialist.