Company: Apex International Recruitment Ltd
Closing Date: 07 Nov 16
Salary (£): On Application
Benefits: Competitive salary and benefits available
Our client are a branded generics company looking to bring the regulatory function in-house and are looking for an experienced regulatory professional to join their team to oversee this. Looking for a regulatory professional who can work autonomously with at least 5 years regulatory experience. Management experience would be good, or someone looking to move into management, however there is no people management required at present only functional management. Competitive package available
Full details available on application
At least 5 years’ experience in post-marketing UK & EU regulatory affairs, particularly prescription-only medicines and also generics plus …
Good understanding of the complexities of MRP and DCP licences including where UK is and is not the RMS
Highly competent to manage variations from start to finish including abridged dossiers for new marketing authorisations (off-patent medicines) and Type 1A, 1B and Type 2 variations.
Hands-on experience of briefing and checking artwork mock-ups and good knowledge of MHRA requirements in this regard.
Cross-functional working with pharmacovigilance team (RMP updates, xEVMPD etc)
Therapy area experience is not essential
Willingness to work in a challenging and dynamic environment where good communication and flexibility are essential attributes
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 firstname.lastname@example.org
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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