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Regulatory CMC Manager

£Negotiable DoE | East Midlands, West Midlands |  Clinical CRO |  Permanent  | Ref:887586



Hayley Shayestehroo

Which team do you work in?

I work in the Regulatory Affairs team.

Which area do you specialise in?

I specialise in recruiting all levels of Regulatory Affairs professionals within pharma, healthcare and medical devices. 

How do you keep up-to-date with the issues in your sector?

Speaking to candidates is the best way to keep updated with changes in the market. I also like to read relevant industry press and relevant articles on LinkedIn. 

What's your favourite film and why?

Mrs Doubtfire - it's an all time classic and I pretty much know it word for word. I love a good thriller too, anything with a good twist at the end. Law Abiding Citizen with Gerard Butler is one of my faves. 

If you could invent one thing what would it be?

Pizza that makes you slim! 

What makes you #DistinctlyDifferent?

I love watching pretty much any sport. I play netball twice a week and come from a footballing family, so have been taught how to do kick ups (my record is 21 without hitting the floor!) Work wise, I like to think I get to know candidates on a deeper level and really understand their drivers and motivations for moving to another company. 


The Role

The Company

This is a fantastic opportunity to join an international leader in the world of Clinical Research. My client are unique in their ability to offer a complete range of services centred around production, implementation and development of innovative treatments and products for the healthcare industry. They are extremely passionate about their employees and pride themselves on a supportive and friendly environment with the highest standards of training:

  • Provides comprehensive support and regular training
  • Friendly, welcoming and supportive environment
  • Varied environment; no two days are the same!


The Role

As the Regulatory CMC Manager you will be responsible for;

  • Managing a small team of CMC Associates whilst remaining hands on
  • Author and review CMC sections of dossiers in preparation for submission
  • Project manage CMC changes to dossiers / technical files
  • Liaise regularly with EU agencies and FDA



You will have the following experience:

  • At least 5 years' experience in a pure CMC role
  • Hands on experience in creating technical files / dossiers ready for submission
  • Authoring/review of CMC related documentation such as IMPD, IND and MAA/NDA
  • Worked on a global basis ideally


What should you do next?

This Regulatory CMC Manager job is a great role and won't be around for long! So don't delay. If you are unsure and need some advice, give me a ring, otherwise just click apply, upload your CV and send, it's really that easy!

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.

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