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Job Details

Regulatory Affairs Manager - Euro Oncology portfolio

Company: JCW Life Sciences
Location:
Reference: WBRAM
Closing Date: 19 Nov 17
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: Bonus, Healthcare, home-working

Job Summary:

A growing Pharmaceutical company is looking to take on a seasoned Regulatory Affairs Manager to manage the maintenance of active licenses but also support licensing of products under development.

Requirements:

Vacancy Details

Role: Regulatory Affairs Manager

Company: Mid-size Pharmaceutical company

Location: South East UK and potential to work from home

Salary/Package: £50,000 to £60,000 per annum + bonus + healthcare + package

 

Responsibilities

General responsibilities involve high-level project management activities in European markets, this includes:

  • Post-Approval Life Cycle Management and Submission activities (License Applications, Variations, Renewals) using MRP/DCP and National procedures
  • Management of Pre-Approval submissions notably MAA's and CTA's
  • Managing regulatory aspects of European clinical trials (Phases I to IV)
  • Participitation in Scientific Advice meetings

Requirements

Candidates must dispaly strong knowledge of the Regulatory process and ability in the management of License Applications

  • 5 years' experience in Post-Approval Life Cycle management submissions
  • Strong understanding of MRP, DCP procedures and European Regulatory Affairs
  • 2 years' MAA submission experience
  • Any direct Regulatory Affairs experience within Clinical Trials, ideally with submission of CTA's is preferred but not essential

 

 NOT THE RIGHT POSITION FOR YOU?

If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to william.bellynck@jcwresourcing.com or call 0203 589 9286 for a confidential discussion about potential opportunities.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

JCW offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.

JCW

JCW is a recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;

  • Pharmacovigilance/Drug Safety
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Medical information
  • Medical Writers
  • Compliance
  • Audit
  • Validation
  • Clinical trials
  • Clinical research
  • Project Management

If you are interested in opportunities, but feel this position is not suitable, please feel free to get in touch on william.bellynck@jcwresourcing.com or 0203 589 9286.

My LinkedIn Profile

https://uk.linkedin.com/pub/william-bellynck/a1/48/19a

A Recruitment Consultant specialising in the Life Sciences sector, placing Clinical Research professionals into interim and permanent positions across the United Kingdom.

If you are a professional looking for work or a hiring manager looking to employ in the Clinical Research space please feel free to reach me on 0203 589 9286 or via email: william.bellynck@jcwresourcing.com

KEYWORDS

Clinical, clinical research, clinical project manager, clinical study manager, clinical trial manager, clinical development, clinical research associate, cra, senior cra, medical, research, regulatory, manager, sales, data, affairs, regulatory affairs, chemist, Marketing, quality, associate, management, director, project, safety, pharmacovigilance, writer, graduate, information, validation, drug, development, pharmaceutical, statistician, representative, business, scientist, pharmacist, trainee, chemistry, sas, drug safety, assurance, clinical research, health, analyst, engineer, statistics, qa, medical, information, nurse, physician, London, rep, oncology, submission, regulatory affairs

Apply for this job: Regulatory Affairs Manager - Euro Oncology portfolio

Contact Information:

Address:  Head Office
27-32 Old Jewry
London
EC2R 8DQ
England
Tel:  +44 (0) 203 589 9300
Fax:  +44 (0) 203 006 8808
Website:  Visit Our Web Site

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