J5630859SurreyPharmaceutical Biotechnology Clinical Permanent£60,000 to £70,000 per annum - Dependent on ExperienceFull Time31/01/2019Regulatory Affairs Regulatory Affairs – EU Regulatory Affairs – Global Regulatory Affairs – Clinical Regulatory Affairs - Biologics
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We are currently looking for a Regulatory Affairs Manager to join an SME 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) to new regions, CTA Management and license life cycle management.
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 in regards to Orphan Drugs.
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 Regulatory Affairs.
2. Proven industry experience of variations and extensions. Preparation of MAA's to EU markets, ideally with experience of centralised procedures, 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.