We are currently looking for a Senior Regulatory Affairs Officer to join a leading Biotherapeutics company based in the Hertfordshire area. As the Senior Regulatory Affairs Officer you will participate in the Regulatory strategy generation for Marketing Authorisations for new products and region expansions.
You will have the opportunity to join a long standing Biopharmaceutical company with an innovative range of Biotherapeutics. You will join a small team where you will have to opportunity to work on Orphan Drug products and use your knowledge of EU regulatory procedures to project manage products from submission, to approval and all the way through to launch.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Develop product licensing strategies for new products and new markets as well as maintaining existing licences through variation and renewal activities.
2. Manage the regulatory aspects and licensing of Orphan Drugs within the US, EU and/or Intercontinental countries where you will communicate directly with the MHRA and other health authorities to gain advice, guidance or clarification of legal issues or submission processes.
3. Communicate directly with relevant internal departments including the manufacturing team to ensure all documentation is generated correctly.
4. You will deputies the Regulatory Affairs Manager in their absence.
To be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology, Pharmacy etc.) in addition to experience in a Regulatory Affairs function where you have been involved in licensing activities. Experience of Orphan Drug classifications and licensing procedures will benefit your application.
2. Proven industry experience in with EU procedures (CP, MRP, DCP and National) for drug development through to product launch in addition to experience of managing post approval activities.
3. A working knowledge and practical experience with Biological Licence Applications (BLA) to the FDA in the US will be beneficial to your application.
Key Words: Regulatory Affairs | MAA | Marketing Authorisation Application | BLA | Biological Licence Application | MHRA | EMA | FDA | Orphan Drug | Drug Development | Licence Submission | Life Cycle Management | Post Marketing Activities | eCTD
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties 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 professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Georgia Walden
- Phone: 0203 910 2980
- Reference: J5631769
- Posted: 9th August 2019
- Expires: 6th September 2019