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Job Details

Regulatory Affairs Associate (contract)

Company: Apex International Recruitment Ltd
Location: Berkshire
Reference: 3110RAA
Closing Date: 02 Jan 17
Type: Contract
Salary (£): On Application
Benefits: Competitive hourly rate available

Job Summary:

Minimum 6 month contract for an experienced regulatory affairs professional to join our client in Berkshire - competitive hourly rate of pay available

Requirements:

DETAILS:

  • Full-time contract position
  • Office based in Berkshire
  • Global pharma company
  • Competitive hourly rate available

 

THE JOB:

  • Maintaining marketing authorisations for a portfolio, liaising with Marketing, Medical, Supply Chain, QA/QP, Pharmacovigilance and teams and communicating key regulatory issues that may affect product developments or product launches.
  • Development and maintenance of regulatory Standard Operating Procedures as required.
  • Maintaining commercial awareness of current and new legislation/guidance to ensure that work is in compliance with the statutory requirements.
  • Gaining marketing authorisations for pharmaceutical products in the assigned territories.
  • Prepares, submits and coordinates national Marketing Authorisation Applications in accordance with local,EU,Global submission requirements.
  • Finalises the national phase of Marketing Authorisation Applications submitted via the EU Mutual Recognition/Decentralised Procedures (generation of Patient Information Leaflet, product labelling and artwork, etc).
  • Ensures submissions are made in agreed timeframe and in line with current health authority regulations to support department schedules/priorities for launch and maintenance.
  • Updates relevant functional stakeholders of any delays and/or schedule conflicts in fulfilling regulatory plans.
  • Liaises with Artwork Coordinator regarding preparation/approval of mock-ups.

Full details available on application

THE CANDIDATE:

  • Regulatory Affairs experience of handling complex licences in terms of full submissions and maintenance.
  • Experience in dealing with the Health authorities
  • Degree in Life Sciences
  • Must be organised and efficient
  • Member of TOPRA an advantage

 

HOW TO APPLY: Interested? – send us your CV now using the Apply button below!!!

However, if this role doesn’t suit your current skill-set, please call Alex on 01227 844466 for further advice.

Only candidates with existing permission to work in the EU can be considered.

About Apex: Apex International is a professional, knowledgeable and niche recruitment agency who recruit across the UK, specialising in  Medical Affairs,  Pharmacovigilance, Regulatory Affairs and Clinical Development (including QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)). For a confidential and professional chat about your job requirements please call Alex on 01227 844466 or email alex@apexrecruitment.com

Our Passion – Your Profession – A consultative approach to recruitment.

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us: www.apexrecruitment.com

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Apply for this job: Regulatory Affairs Associate (contract)

Contact Information:

Address:  Apex International
The Blue Room, Kent Enterprise House, 1 The Links, Herne Bay, Kent,
CT6 7GQ
England
Tel:  01227 844466
Fax:  01227 208590
Website:  Visit Our Web Site

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