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Principal Regulatory Writer

£negotiable + benefits | Home based, Cheshire, Greater Manchester |  Regulatory Affairs, Regulatory Consultancy |  Permanent  | Ref:889235

The Role

Principal Regulatory Writer - Leading Consultancy - South Manchester / Cheshire with some remote working - £neg + bens

This is an exciting time to join an expanding, highly successful Consultancy on a permanent basis based in South Manchester / Cheshire. They offer excellent training and development opportunities as well as great career progression and an excellent work/life balance.

  • Independently owned company
  • Excellent career progression opportunities
  • Great training and development
  • Exciting and innovative projects

 

The Company

This is an exciting time to join an expanding, highly successful Consultancy based in South Manchester / Cheshire. You'll be working on exciting projects with some of the biggest, most reputable pharma clients. This role offers huge variety and great career development.

  • Highly successful Consultancy working with high profile pharmaceutical clients
  • Privately owned company
  • Highly varied role, working on exciting projects for leading pharma clients
  • Great in house support, training and development

 

The Role

The Principal Regulatory Writer will be responsible for leading the planning and delivery of regulatory submissions and other large regulatory projects in a concise and accurate manner.

  • Plan and deliver regulatory submissions on behalf of pharmaceutical clients
  • Prepare clinical regulatory documents across multiple therapy areas
  • Evaluate scientific data
  • Work on projects independently as well as group projects

 

You

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

  • Regulatory writing experience
  • Experience writing clinical regulatory documents to a high standard
  • Strong understanding of clinical development and ICH guidelines
  • Experience authoring regulatory documentation such as CTD modules, response documents and regulatory briefing documents
  • Degree educated in life sciences / pharmaceutical science

 

What should you do next?

This Principal Regulatory Writer role is one not to be missed; it encompasses the opportunity to work in a fast paced environment on new and exciting projects. 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 is your greatest fear?

I don’t really have one, but if there’s one thing I’m well not keen for it would be snakes or an army of ants…

 

How would your friends describe you in three words?

Funny, healthy, sporty

 

You’re stranded on a desert island – what one thing could you not live without?

Bear Grylls! He’d have us rescued in no time!

 

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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