Regulatory Project Manager

Employer
CK Group
Location
Brentford
Salary
£374.69PAYE/£489.83UMB
Closing date
28 May 2022

View more

Sector
Regulatory Affairs
Contract Type
Contract
Hours
Full Time
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Job Details

CK Group are recruiting for a Regulatory Project Manager to join a company in the healthcare industry at their site based in Brentford initially on an 12 month contract.

Rate:
£374.69 per day PAYE / £489.83 Umbrella per day

Regulatory Project Manager Role:
• Responsible for the regulatory management of clinical assets and MAs for a a portfolio of products for Ireland and UK
• Is the primary interface with the local regulatory authorities
• Ensure product information, Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant
• Responsible for the local management of product registration documents in regulatory databases and repositories
• Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews

Your Background:
• Graduate/PhD level or equivalent, with experience in the pharmaceutical industry, including regulatory experience
• In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio.
• Knowledge of drug development process and regulatory affairs
• Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
• Ability to work in a complex environment with good interpersonal and influencing skills

Ideal candidate:
• Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term.
• Can define regulatory strategy
• Has an in-depth understanding of regulatory governance, medical and safety

Company:
Our client is a global healthcare company, taking on some of the world's biggest healthcare challenges.

Location:
This Regulatory Project Manager role is based at our clients site in Brentford, Greater London.

Apply:
For more information, or to apply for this Regulatory Project Manager position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52935.

It is essential that applicants hold entitlement to work in the UK.
Please note that the successful applicant will be required to engage via an FCSA-accredited and CK-approved umbrella company and the rate of pay indicated is an umbrella rate.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB

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