Job Reference: J5631684
Updated On: 13/06/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Regulatory Affairs Associate to join a leading Generics Pharmaceutical company based in the Heathrow area. As the Senior Regulatory Affairs Associate you will be responsible for the preparation, review and authorisation of CMC documentation. You will work on new MA submission as well as the variation and renewal of the company's existing portfolio.
This position would suit a Regulatory professional with exposure CMC documentation who is looking to gain experience in authoring Module 3 documentation or an experienced CMC Regulatory professional who is looking to develop in their career.
Key Duties and ResponsibilitiesYour duties as the Senior Regulatory Affairs Associate will be varied however the key duties and responsibilities are as follows:
1. Prepare, review and authorise CMC (Module 3) documents for Generic products including in-licensed products.
2. Prepare, review and publish different variation including Type 1A, Type 1B and Type 2 including the transfer of National licences to EU procedures including MRP and DCP.
3. Provide regulatory advice to support the UK & EU strategy as well as supporting external clients.
4. Support a small team of Regulatory Affairs Assistants and Associates to ensure internal and external Regulations are maintained.
Role RequirementsTo be successful in your application to this exciting opportunity as the Senior Regulatory Affairs Associate we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g. Pharmacology, Pharmacy, Chemistry etc.) in addition to experience in a Regulatory Affairs environment.
2. Proven industry experience with CMC (module 3) documentation including the handling of a variety of variations and renewals.
3. A working knowledge and practical experience with pre-approval activities such as Dossier review would be beneficial to your applications.
Key Words: Regulatory Affairs | Module 3 | CMC | Variations | Renewals | eCTD | Regulatory submissions | MRP | DCP | Pre-approval | Generics | Pharmaceutical | EU | UK
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