Job Vacancy Details
Director of Regulatory and Medical Affairs
Leading Blue Chip
Slough
Permanent ⁄ £100000
Updated April 29, 2012
Key responsibilities for the position:
Medical Affairs
• Deliver the medical, regulatory and safety strategy and ensure on-going compliance within the total UK/Ireland/Scanda region
• Provide medical and scientific expertise for internal and external customers with respect to local businesses' needs.
• Providing medical leadership to business activities; ensuring Marketing and Sales activities are grounded in good medical science.
• Supporting and advising Commercial groups (e.g., Marketing and Sales) through information gathering, processing and medical scientific statements.
• Addressing medical and scientific questions from Health Care professionals, third parties (distribution partners, external sales forces, etc.) and patients.
• Reviewing regulatory texts (e.g. PIL, SPC) and advertising copy for medical content.
• Planning and coordination of clinical trials and Post Marketing Surveillance Studies of products developed and or distributed by Reckitt Benckiser - UK/Ireland/Scanda.
• Participating in development projects (concept, decision support)
• Anticipating and managing proactively medical issues and perceived risks in cooperation with Marketing, Category R&D and others.
• Developing scientific publications / support of scientific PR activities
• Developing and maintaining a network of Key Opinion Leaders for the respective drug category (Analgesics, Upper Respiratory Tract, GI Tract, etc.)
• Networking and bonding with scientific editorial staff
• Screening scientific literature
• Negotiating and contracting external scientific services (e.g. consultants, research organisations)
• Communicating with the Global Medical Affairs Group
Regulatory Affairs - All Products
• Ensure the registration and regulatory compliance of UK/Ireland/Scanda marketed products with relevant national and European regulatory requirements to bring competitive advantage to our brands.
• Documentation Management System:
• Ensuring the compilation of national dossiers for submissions to authorities
• Ensuring the preparation, maintenance and update of product registration/license and regulatory compliance files.
• Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation app
Who we're looking for
• Medical qualifications, at least MBBS / MBChB or equivalent; preferably a higher medical qualification, such as Membership of the Royal College of Physicians and/or Faculty of Pharmaceutical Medicine.
• Registered with national professional regulatory bodies, such as the General Medical Council in the UK (Full registration) plus at least two years' clinical work.
• Experience in the OTC market and within a FMCG environment, or within a pharmaceutical environment, with experience managing Medical, Regulatory and/or Safety functions.
• Broad knowledge of UK/Ireland/Scanda regulatory and healthcare systems
• Experience in managing a team of line reports, including second line reports; as well as managing remotely across countries.
• Experience in handling corporate crisis management and issues resolution.
• Demonstrated ability to handle competing priorities effectively.
• Sound performer in interacting with, and influencing regulatory authorities and political lobbies.
• Experience with recruitment, management and development of people.
• Proven track record in active collaboration with R&D and non-R&D functions as well as third parties.
• Proven experience in leading multi-functional and multi-cultural project teams, virtually.
• Clear and logical thinker with the ability to recognize patterns and develop innovative solutions.
• Ability to apply argumentat
About our client
Our client is a well know, blue chip, consumer healthcare organisation
What's on offer
A competitive package to attract the best applicants is on offer
Michael Page Contact
For further info, apply or phone on 0113 388 9000.
Job Ref: 13219846
Your application will be sent to Emma Whittle.
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