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Senior Regulatory Affairs Officer - Pharma

Location: Manchester, Greater Manchester Salary: £35000 - £40000 per annum
Sector: Pharmaceuticals Specialism:
Type: Temporary Contact: Daniel Paine

Senior Regulatory Affairs Officer / Executive

I am working with a leading development and manufacturing organisation in the pharmaceutical industry based near Manchester that are actively looking for a Senior Regulatory Affairs Officer / Executive to join their team.

The Senior Regulatory Affairs Officer / Executive will have the following responsibilities:

  • Maintain the marketing authorisations
  • Prepare the variations and new marketing authorisation applications in the UK and Europe in eCTD format
  • Compliance reviews of internal and external manufacturing documents, batch records, protocols, API quality control records, validation protocols, etc.
  • Write and review standard operating procedures and instructions
  • GAP analysis / MA review

The Senior Regulatory Affairs Officer / Executive must have the following requirements:

  • Degree in Life Sciences, Pharmaceutical Sciences or equivalent;
  • Min 6 years' experience in regulatory affairs
  • Must have a strong regulatory background with knowledge of EU process and legislation
  • Experience in eCTD and writing CMC CTD documents
  • Great written and spoken English

My client is keen to get the right fit for their team; so, if you feel as though you have the skills, experience and desire to be an exceptional Senior Regulatory Affairs Officer / Executive; then this is the opportunity for you. Apply today!

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for an interview. A copy of our privacy policy can be found here: https://www.goldgroup.co.uk/about-us/privacy-policy. Gold Group is an equal opportunity & diversity employer. A copy of our equal opportunity & diversity policy can be found here: https://www.goldgroup.co.uk/about-us/equality-and-diversity-policy