J3179BerkshirePharmaceutical Contract / Temporary / Interim£35.00 to £40.00 per hourFull Time02/11/2016Regulatory Affairs
Regulatory Affairs – Global
Regulatory Affairs - CMC
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Hyper Recruitment Solutions are currently looking for a Regulatory Officer to join a leading pharmaceutical company based in the Berkshire area. As the Regulatory Officer you will be responsible for maintaining marketing authorisations for a portfolio, liaising with Marketing, Medical, Supply Chain, QA/QP, Pharmacovigilance and STADA teams. You will also communicate key regulatory issues that may affect product developments or product launches.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Officer will be varied however the key duties and responsibilities are as follows:
1. You will prepare, submit and coordinate national Marketing Authorisation Applications in accordance with local, EU, and global submission requirements.
2. As the Regulatory Officer you will finalise the national phase of Marketing Authorisation Applications submitted via the EU Mutual Recognition/Decentralised Procedures (generation of Patient Information Leaflet, product labelling and artwork, etc).
3. You will compile and submit CMC variations (CP/DCP/MRP/National) in line with the variation regulation, SOPs (where relevant) and national Competent Authority requirements.
4. As the Regulatory Officer you will provide QPs with current licence information to ensure product is released to respective markets in compliance with their registered technical details in that market (MA licence).
To be successful in your application to this exciting opportunity as the Regulatory Officer we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences.
2. Regulatory Affairs experience of handling complex licences in terms of full submissions and maintenance.
3. A working knowledge and practical experience dealing with the Health authorities.
Key Words: Global marketing authorisations, decentralised procedures, artwork, life cycle management, submissions, variations, pharmaceutical, regulatory affairs, CMC
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.