Description
Key aspects of the role:- Ensure the registration and regulatory compliance of marketed products with relevant National and European regulatory requirements to bring competitive advantage to the brands
- Monitoring and interpreting UK&I and Scandinavian regulatory issues
- Ensuring the compilation of national dossiers for submissions to authorities
- Ensuring the preparation, maintenance and updates of product registrations/licenses and regulatory compliance files
- Ensuring the amendment of registration dossiers as necessary for country-specific regulatory requirements
- Negotiating with governmental authorities to obtain rapid approvals
- National management of MRPs
- Assemble Compliance Dossiers for manufacturing of products for the local markets
- Developing and reviewing regulatory texts (e.g., PIL, SPC, packaging) including coordination of translations
- Developing scientific publications / support of scientific PR activities
- Developing and maintaining a network of Key Opinion Leaders for the respective drug category (Analgesics, Cold Cough Flu, GI etc.)
- Networking with scientific editorial staff
- Negotiating and contracting external scientific services
Desired Skills:
- 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&I and Scandinavian regulatory and healthcare systems
- 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
- Proven experience in leading multi-functional and multi-cultural project teams as well as direct line reports
- Clear and logical thinker with the ability to recognize patterns and develop innovative solutions
- Ability to influence key stake holders at all levels, externally and internally
- Pro-active self-direction with a high level of initiative and persistence and a very much hands on approach to results delivery
For further information, please contact Karan Baxi on or via email on ka.baxi(a)realstaffing.com who specialises in placing regulatory affairs professionals in the OTC, Consumer Health and FMCG industries in varying levels of seniority.
Additionally, the wider Regulatory team have a range of roles that they are currently recruiting for so if you are looking for something other than this role, please do get in touch on .