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Senior/Principal Regulatory Writer

£30k-£60k + bonus | Cheshire |  CRO, Pharmaceutical Company/Sponsor side |  Permanent  | Ref:885877



Katie Goulbourn

Which team do you work in?
I work within the Drug Development team.

Which area do you specialise in?
I specialise in recruiting Junior to Director level Regulatory Affairs & Quality Assurance professionals within Pharma, Healthcare, Medical Devices and Animal Health. 

How do you keep up-to-date with the issues in your sector?
Speaking daily with clients and candidates keeps me on top of the latest industry trends and news, combined with regularly visiting relevant websites and reading articles.

What's your favourite film and why?
I absolutely love a good rom-com, my favourite would have to be The Holiday.

If you could invent one thing what would it be?
Trackable GPS microchips for cats and dogs - how has this not been invented yet!?


The Role

Senior / Principal Regulatory Writer, £30k-£60k + 12% bonus + fantastic benefits, Cheshire

A Cheshire based healthcare communications agency, specialising in communication planning and regulatory services are experiencing rapid growth and therefore require an additional Senior Regulatory Writer and a Principal Regulatory Writer to join their Regulatory team.


The Company

Working with a number of high profile pharmaceutical clients providing regulatory submissions and clinical documents.

  • Friendly, supportive team environment in open plan modern offices with the wow factor, including onsite restaurant, coffee shop and located in the beautiful Cheshire countryside

  • Extensive list of company benefits including annual profit-related bonus (8%-12%), 5% pension contribution, private health insurance, critical illness cover, childcare vouchers, cycle to work scheme, 25 days annual leave + bank holidays, homeworking opportunities

  • Additional perks including 1 day release for voluntary work, £50 birthday donation to a charity of your choice, discounts on local gym, restaurants and retail, refreshments in the office,

  • In-house training development plan and external industry recognised training sessions

  • Free onsite staff parking and commutable via train


The Role

As the Senior Regulatory Writer / Principal Regulatory Writer, reporting into the Head of Regulatory Writing, you will have a varied workload across numerous therapy areas and document types.

  • Authoring of regulatory submission documents across various therapy areas

  • Preparing clinical study reports

  • Contributing to regulatory strategy

  • Liaising with clients via phone, webex and face to face meetings, with the opportunity to travel across the UK, Europe and the US

  • At Principal level you will be confident leading complex projects and overseeing junior team members and freelancers

  • You will gain exposure and experience across a wide platform



To be considered for this opportunity candidates will have:

  • A minimum of 2 years Regulatory writing experience within a client facing role

  • Experience contributing to strategic Regulatory planning

  • Experience authoring and preparing CTD and clinical study reports

  • The ability to evaluate scientific data and report results accurately

  • Experience supporting more junior members of the team is beneficial


What should you do next?

These Senior Regulatory Writer / Principal Regulatory Writer jobs are great roles 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!

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