Job Reference: J5632924
Updated On: 10/02/2020
Status: Now Interviewing
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Role OverviewWe are currently looking for a Regulatory Affairs Contractor to join a leading Pharmaceutical company based in the Wiltshire area. As the Regulatory Affairs Contractor you will be responsible for supporting an EU Centralised application to the European Medicines Agency for a biological product.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Contractor will be varied however the key duties and responsibilities are as follows:
1. Prepare Marketing Authorisation Applications (MAA's) for submission to the European Medicines Agency (EU Market) (Ideally biologics products)
2. Coordinate, review, evaluate and prepare applications for Biologics products.
3. The Regulatory Affairs Contractor will prepare and review formal responses to regulatory authorities review questions
4. Review the requirements for submitting a Centralised Procedure filing to the European Medicines Agency (EMA)
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Contractor we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific discipline
2. Proven industry experience with submitting Marketing Authorisation Applications (MAA's) to the European Medicines Agency (EU)
3. A working knowledge and practical experience with European (EU) Centralised Procedure
Key Words: Marketing Authorisations / MA / MAA / EU / EMA / Europe / Centralised Procedures / Biologics / RA / Regulatory Affairs / Reg Affairs / Biologics / Contract / Contractor
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.
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