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Regulatory Affairs Officer

Location: Manchester, Greater Manchester Salary: £35000 - £40000 per annum
Sector: Life Sciences Type: Contract
Contact: Jeremy Farley Job Published: 12 days ago

Job Title: Regulatory Affairs Officer

Location: Manchester

Salary: £35,000 - £40,000

Term: 12 Months Fixed Term Contract

Key Skills: Regulatory Affairs, Pharmaceutical, FTC, eCTD, SOP, CMC, Module 3, Gap Analysis, Medical, EU, Life Science, SmPC, Manufacturing

An experienced Regulatory Affairs Officer is required to join my client to join the Regulatory Affairs team in the preparation or variations and new marketing authorisation applications within the UK and Europe.

Working from site, this is a truly fantastic opportunity for the right person. If this sounds like an opportunity for you, please read on!

The Role:

So, what will you be doing as a Regulatory Affairs Officer?

  • Maintenance of marketing authorisations
  • Reviewing, writing and advising on SmPC and artworks in line with current legislation
  • Carrying out of compliance reviews of internal & external manufacturing and other site documents - Batch packaging & manufacturing records, stability protocols, Quality Control
  • Writing & reviewing of SOPs & work instructions
  • GAP Analysis/MA Review
  • Provide assistance to the Pharmacovigilance Provider with Medical queries
  • Management of various regulatory projects - Provision of advice, strategies

What are we looking for in our next Regulatory Affairs Officer?

  • Degree Educated in Medical Sciences, Pharmaceutical Sciences
  • Minimum of 3 years' experience in Regulatory Affairs
  • Strong regulatory background with knowledge of EU Regulatory processes and legislative procedures
  • Experience in compiling eCTD

My client is keen to get this position filled ASAP, so if you feel you have the skills and desire to provide passion and drive as the next Regulatory Affairs Officer, this is the opportunity for you!

So, if you are interested in joining a well-established, renowned, globally recognised organisation working with experts in their field as the next Regulatory Affairs Officer, hit that apply button now!

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