Job Reference: J5633387
Updated On: 06/07/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Global Pharmaceutical company based in the Berkshire. As the Senior Regulatory Affairs Officer you will be responsible for a range of regulatory activities in product submission, life cycle management of in-licensed and Generic CNS products as well as Regulatory compliance.
Key Duties and ResponsibilitiesYour duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:
1. Assist with the preparation, submission and coordination of Marketing Authorisation Applications in accordance with EU requirements through Mutual Recognition and Decentralised procedures. You will finalise the national phases by generating Patient Information Leaflets, product labelling and artwork.
2. You will compile and submit product variations and renewals in line with DCP , MRP and National procedures. You will also have exposure to regulatory operations through compiling in eCTD and NeeS format.
3. You will liaise with 3rd party Manufacturers to ensure you have the correct documentation and to ensure the right licenses are obtained.
4. You will ensure the company remains compliant in terms of Regulatory activities. You will ensure documentation is appropriately stored and managed and raise change controls as required.
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, Chemistry, Biology etc.) in addition to experience in a Regulatory Affairs focused position, ideally with EU experience.
2. Proven industry experience of Regulatory Submissions to Global authorities including new MAA and Life-cycle management as well as experience with negotiating positive outcomes with Health Authorities
3. A working knowledge and practical experience with the preparation of MAA, variations and renewals for MRP and DC procedures.
Key Words: Regulatory Affairs | Associate | Officer | Marketing Authorisation Applications | MAA | Mutual Recognition Procedures | MRP | Decentralised Procedures | DCP | eCTD | NeeS
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