Description
You will report directly to the Regulatory Manager and will need the following key competencies:- Define content, compile, and assist in the compilation of high quality dossiers for submission/resubmission, to relevant EU Health Authorities
- Develop and maintain strong relationships with key personnel in the regulatory authorities, to optimise the speed and outcome of the review process
- In respect of technical variations, liaise proactively with colleagues in technical line functions to accurately specify dossier content so expediting application review and thereby protecting continuity of product supply
- Provide comprehensive and appropriately updated records of product licence details to relevant functions to enable company-wide regulatory compliance
- Advise marketing function on the most commercially acceptable means to implement mandatory regulatory requirements for pack labels
- Respond to requests from Global Regulatory Affairs in relation to Licence Database information and Expert Certification for overseas markets
- Maintain a high level of awareness of appropriate regulatory legislation to maximise the commercial relevance of regulatory advice
The successful candidate must have a science (or related) degree, and be an effective communicator across all levels in the organisation. Should have a good working knowledge of appropriate EU and UK regulatory framework for pharmaceutical products. Needs to have direct and recent experience with the UK and Irish Health Authority in managing MAAs (national, MRP,DCP) and licence maintenance work such as variation applications.
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 .