Job Reference: J5632099
Updated On: 23/08/2019
Status: Now Interviewing
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Role OverviewWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in North London. As the Senior Regulatory Affairs Officer you will be responsible for the preparation review and submission of Variations and Renewals to EU and RoW markets.
You will manage the entire life cycle process and will communicate directly with Regulatory Authorities including the EMA. This position would suit an RA professional looking to gain more experience with EU Centralised procedures.
Key Duties and ResponsibilitiesYour duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Prepare, review and publish different variation including Type 1A, Type 1B and Type 2 as well as renewal of product licences.
2. Support licensing activities for existing Marketing Authorisation applications to EU and ROW markets including Europe, South America, Asia and the Middle East.
3. Work cross functionally to support Regulatory activities across the business and ensure compliance to Regulatory guidelines.
Role RequirementsTo 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. Pharmacology, Pharmacy, Chemistry etc.) in addition to experience in a Regulatory Affairs environment.
2. Proven industry experience of preparing and submitting Variations and Renewals to a range of markets.
3. A working knowledge of Animal Health and Veterinary products would be a benefit to your application as well as the VMD (Veterinary Medicines Directorate).
Key Words: Regulatory Affairs | Module 3 | CMC | Variations | Renewals | eCTD | Regulatory submissions | MRP | DCP | Pre-approval | Generics | Pharmaceutical | EU | UK | VMD | Animal Health | Veterinary Medicines Directorate
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