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Job Details

Head of Regulatory Affairs

Company: Apex International Recruitment Ltd
Location: Hertfordshire
Reference: 2107HRA
Closing Date: 25 Oct 17
Type: Permanent
Salary (£): On Application
Benefits: Competitive salary and benefits available

Job Summary:

Senior position with our client for a Head of Regulatory Affairs working in new products and post-approval maintenance - competitive package available

Requirements:

DETAILS:

  • Full-time permanent position
  • Office based in Hertfordshire
  • Global pharma company
  • Competitive package

 

THE JOB:

  • Ensuring that a company's products comply with the regulations of the MHRA;
  • Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to;
  • Collecting, collating and evaluating scientific data that has been researched by colleagues,
  • Developing and writing clear arguments and explanations for new product licences and licence renewals,
  • Monitoring and setting timelines for licence variations and renewal approvals;
  • Advising cross departments, scientists and manufacturers on regulatory requirements;
  • Providing strategic advice to senior management throughout the development of a new product, and
  • post-approval maintenance,
  • Project managing teams of colleagues involved with the development of new products,
  • Undertaking and managing regulatory inspections,
  • Reviewing company practices and providing advice on changes to systems,
  • Liaising with, and making presentations to, regulatory authorities and to senior management,
  • Negotiating with regulatory authorities for marketing authorisation. 

Full details available on application

THE CANDIDATE:

  • Demonstrated leadership, management of team including motivating
  • Strong negotiation skills, proven interaction and collaboration with competent agencies (MHRA/HPRA/DOH/Home Office)
  • Extensive UK/ IE Affiliate RA knowledge (at least 8+ years), 
  • Excellent understanding of the EU/national legislation governing the approval of products

 

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: Head of Regulatory Affairs

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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