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Regulatory Affairs Officer

£Excellent basic salary plus benefits | Greater Manchester |  Regulatory Affairs, Pharmaceutical Company/Sponsor side |  Permanent  | Ref:890146

The Role

Regulatory Affairs Officer - Pharma - Pharmaceutical Manufacturer and Distributor - Bolton - £27-30,000 + bens

The Regulatory Affairs Officer will be responsible for all regulatory matters for the business. This will include compiling dossiers / technical files for new products and managing the submission to the MHRA.

 

The Company

This is an exciting time to join an expanding, pharmaceutical manufacturer/distributor based at their offices in Bolton.

  • Established over 40 years ago
  • Manufacture and distribute P and OTC medicines mainly within analgesics
  • Great career opportunities

 

The Role

The Regulatory Affairs Officer will be responsible managing all regulatory matters for the business. This will include (but not limited to).

  • Prepare and submit applications to the MHRA (UK) via National Procedure including new licence applications, variations, renewals, artwork changes, RFIs,
  • Variations: Type 1A, 1B, II,
  • Reclassification of Medicines
  • Deficiency responses to authorities
  • Act as a point of contact for all regulatory matters internally / externally
  • Maintain up-to-date records and documentation in relation to Marketing Authorisations

 

You

To apply for this role as a Regulatory Affairs Officer our client is hoping for someone with the following skills and experience;

  • 1-3 years experience within regulatory affairs
  • Pharmacy, Life Science or Relevant Scientific Degree
  • Good knowledge and understanding of the current UK and European regulations
  • Exposure to NeeS/eCTD format and electronic submission gateways is preferable
  • Experience with Generic products and MRP/DCP submissions is advantageous
  • Experience in e-publishing using standard software platforms

 

What should you do next?

This Regulatory Affairs Officer role is one not to be missed; it encompasses the opportunity to work in a growing healthcare company who are at the forefront of their industry. To discuss further, please submit your current CV.

Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

Consultant

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Hayley Shayestehroo

Which team and area do you work/specialise in?

I work in the Regulatory Affairs team and recruit for Regulatory Affairs professionals at all levels within Pharma, Medical Devices companies and Regulatory Consultancies

What are some of the typical roles you cover?

I cover Regulatory Affairs positions at all levels within Pharma, Medical Devices and Regulatory Consultancies, these typically include;

Regulatory Affairs Associate jobs, Regulatory Affairs Executive jobs, Regulatory Affairs Senior Associate jobs, Regulatory Affairs Manager jobs, Regulatory Affairs Senior Manager jobs, Regulatory Affairs Director jobs, Regulatory Affairs Consultant jobs, Regulatory Writer jobs and Medical Writer jobs.

What are the hot issues in your sector currently?

Within Medical Devices it is the transition from MDD to MDR in May 2020. A lot of medical device companies are hiring Regulatory professionals to prepare their company for the transition

What’s makes you #DistinctlyDifferent?

I take pride in getting to know my candidates on a personal level as well as professional. Changing jobs is a big decision for most people so I like to ensure I am placing my candidates in a role that not only matches their career aspirations but also suits their personal situation and key motivations.

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