Regulatory Manager ROW

Recruiter
i Pharm Consulting
Location
Cambridgeshire
Posted
05 Oct 2017
Closes
02 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Manager - ROWJOB SUMMARY:i-Pharm Regulatory are recruiting for a Regulatory Manager position which will the regional Lead in preparation of submissions which may include, but are not restricted to, new license applications, PSURs/RMPs, responses to questions and renewals. Strong ROW experience required. Candidates must be eligible to work in the UK.lOCATION: CambridgeRESPONSIBILITIES:- Preparation and coordination of designated regulatory labeling variations submissions for marketed products across the EE&ME region.- Liaises with regulatory, manufacturing and other parties as appropriate, to ensure the product packaging and associated information is updated and maintained in accordance with product licences in international territories.- Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals, in designated markets of responsibilityThe ideal candidate:- Prior experience in regulatory submissions is required and at least 5 years relevant industry experience.-Direct experience across ROW markets is highly desirable. - An understanding of regulatory requirements, including ICH requirements and regional requirements and developing an appreciation of current global and regional trends in Regulatory Affairs. TO APPLYIf you would like to discuss this vacancy further, please call i-Pharm Regulatory Team Leader Niall Behan on +44 (0)20 3189 0463, or email nbehan@i-pharmconsulting.com. If this role is not suitable, Joe is also available to discuss other possible positions or answer any general questions regarding your career and the current market.ABOUT i-PHARM REGULATORYi-Pharm Regulatory is a specialist Recruitment team working wholly within the Regulatory Affairs market. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). I-Pharm Regulatory is a team within the larger organisation i-Pharm consulting which provides candidates in areas such as: Clinical Operations, Pharmacovigilance, Biometrics, Project Managements, Quality Assurance and Health Economics. Visit our website to see our extensive current vacancies:www.i-pharmconsulting.comKEY WORDSRegulatory affairs, senior regulatory affairs Manager,Cambridge, senior regulatory affairs, ROW, Emerging Markets, regulatory affairs, reg affairs, regulatory affairs manager, regulatory affairs senior manager, regulatory affairs director, development, regulatory affairs manager, regulatory intelligence, Cambridgeshire, Cambridge, Hertford, Hertfordshire, London, East of England, London, West London, Uxbridge, Maidenhead, Slough, Reading