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Hyper Recruitment Solutions are happy to announce that we are supporting a leading Biopharmaceutical company in the West Sussex area with the recruitment into their Regulatory Affairs department. The Biologics company with a focus on immunotherapies are looking for an experienced Regulatory Affairs Manager to lead a small, multi focused team in the Licensing of new products, Regulation of Clinical Trials activity as well as the Maintenance of current product regulations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. Lead, motivate and manage a small team of Regulatory Affairs Officers and direct the development, appraisal and training of your team ensuring the highest standards are adhered to.
2. Ensure the compliance to GMP regulations; the review and approval of IND submissions for licensing by the FDA; submission of CTA to support clinical trial applications as well as maintenance documentation for current licensed and unlicensed products.
3. Be actively involved in the regulatory strategy of the company and prepare and review new product dossiers and annual updates. Approve labelling and packaging text and assisting the marketing teams with advertising regulations.
4. Communicate with regulatory agencies in the UK, EU and USA.
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 in addition to extensive experience in a Regulatory Affairs with a pharmaceutical or biopharmaceutical setting.
2. Proven industry experience of writing submission documentation including CTA and IND. Experience of working with regulatory boards in the EU and USA is desirable e.g. FDA
3. A working knowledge and practical experience of line managing a team of regulatory professionals
Key Words: Regulatory Affairs | Biologics | Immunotherapies | CTA | IND | FDA | GMP | EMA | Team Leader | Management | Clinical Trials | Retrospective Licensing
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.