J562633SurreyPharmaceutical Biotechnology PermanentCompetitiveFull Time01/08/2018Regulatory Affairs Regulatory Affairs – UK Regulatory Affairs – EU Regulatory Affairs – Clinical Regulatory Affairs -Operations
Share this job
Other jobs with similar skills
Regulatory Affairs Manager Hyper Recruitment Solutions are happy to announce that we are supporting a leading Biopharmaceutical company in the West Sussex area with the recruitm... View Job
Regulatory Affairs Manager An exciting opportunity has become available to join a leading Regulatory Consultancy as their Regulatory Affairs Manager in the Essex area. As the Re... View Job
Senior Manager of Regulatory Affairs We are currently looking for a Senior Manager of Regulatory Affairs to join a leading Pharmaceutical company based in the Berkshire area. As the Senio... View Job
We are currently looking for a Regulatory Affairs Manager to join a Global Pharmaceutical company based in the Surrey area. As the Regulatory Affairs Manager you will be responsible for the regulatory management of Orphan drug products where you will support regulatory strategy as well as Marketing Authorisation Applications (MAA), Clinical Trial Applications and licensing variations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. Regulatory - Complete Applications and submissions to national regulatory authorities as well as maintaining current submissions and variations.
2. CTA - Prepare documentation to support Clinical Trial Applications in Europe as well as submitting to ethical committees.
3. Labelling and Packaging - Create country specific secondary packaging material and obtain approvals on labelling text and design by competent authorities.
4. Pricing - Provide guidance on pricing and reimbursement procedures in selected countries.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Pharmacy, Biological Sciences etc.) in addition to experience within a Senior Regulatory position.
2. Proven industry experience in the preparation of MAA's to EU markets, ideally with experience of centralised procedures. Experience of variations and extensions would be beneficial to your application.
3. A working knowledge and practical experience with preparing CTA's as well as labelling experience will help you in this exciting role. Exposure to Orphan Drug requirements is beneficial but not required.
Key Words: Regulatory Affairs , Manager , MAA , Marketing Authorisation Applications , CTA. Clinical Trial Applications , CP , Centralised Procedures , EU , EMA , Orphan Product , Post Marketing Approval , Variations , Consumer Health , Generic , Pharmaceutical
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.