Regulatory Product lead
ProClinical currently has a fantastic opportunity for you to join an international pharmaceutical organisation as a Regulatory Product lead (UK & Ireland) based in London. This company focus on developing treatments for conditions where the impact of the medicines can make an immediate and tangible difference. They provide treatments in Neuroscience, Rare Diseases and other medical sectors.
- Operational regulatory affairs activities, involving interface from LOC to European and Global RA
- Ensuring conformance to national and EU Drug Laws
- Maintaining labelling information to internal and external partners
- Communicating with national regulatory authority and regulatory institutions if required in collaboration with EU strategists
- Supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams.
- Approval of specific advertising and promotional materials in accordance with UK/IE national legislation and codes of practice.
- Ensuring adherence to company standards and local laws
Skills and Requirements:
- UK based at our offices in Paddington. Travel minimum, potentially once / year
- Manager level although no direct line reports. Must have experience in taking on a leadership role, mentoring more junior members of staff when the hiring manager is out of the office and taking on projects
- Min of 5 years solid Reg Affairs experience
- Strong reg affairs affiliate experience in the UK & Ireland (EU centric candidates not suitable)
- Experience of working with commercial teams
- Advertising & Promotional experience - will need to have a solid understanding of this area rather than extensive experience as they will undertake internal training
- Strong team working skills and flexibility
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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