Regulatory Affairs Manager - Team Leader

West Sussex
Competitve Salary
11 Oct 2018
08 Nov 2018
Georgia Walden
Contract Type
Full Time
A leading Biopharmaceutical company in the South East of the UK are looking to recruit a Regulatory Affairs Manager with line management experience. The successful applicant will lead a small, multi focused team in a range of regulatory activities including MAA submissions, Clinical Trial applications to Europe and the FDA as well as the maintenance of existing licenses.


Your duties as the Regulatory Affairs Manager - Team Leader 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 review and approval of INDs to the FDA; submission of CTA to support clinical trial applications as well as maintenance of 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 - Team Leader 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, MHRA or National Proceedures

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 | MAA | Variations | Strategy

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.

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