Regulatory Affairs Adviser
|Job Title:||Regulatory Affairs Adviser|
|Contact Name:||Alastair McCartney|
|Job Published:||July 12, 2017 15:14|
- Creation, compilation and submission to MHRA of MA applications, renewals and variations of MA (including switch applications and drafting expert statements). Maintenance of medicine dossiers, medical device technical files, cosmetic PIFs, VMS review sheets within agreed portfolio to statutory requirements.
- Creation of SmPCs, technical leaflets, PILs and labels and overseeing the internal approval to produce finalised version, including for MHRA submission when required.
- Introduce new products in the UK and/or Malta by contributing to the development process; proposing regulatory strategies for local and global products, and advising on data requirements where UK and/or Malta are target markets for global projects.
- Contribute to the UK CH development and marketing process by providing regulatory advice to internal partners including Medical, Marketing, Quality, Business Development, I&D and global Regulatory Affairs.
- Understand and communicate with internal parties the impact of regulatory information and intelligence relevant to the CH business. To advise line manager of project-related issues.
- Liaison with Authorities (including MHRA, Notified Bodies, Trading Standards, FSA), global Regulatory Affairs and local Medical Department, together with prompt professional responses to questions. Receipt and checking of product approvals, circulation of formal documents to appropriate personnel and efficient maintenance of Regulatory files and databases (in conjunction with Regulatory Operations Executive). Checking incoming documentation from global Regulatory Affairs to ensure MAs are in compliance.
- Participate in SOP review process and update SOPs related to principal accountabilities as required.
- Ensure compliance with all relevant codes of practice, e.g. ABPI Code of Practice, Proprietary Association of Great Britain, Medicines Act, MHRA guidelines and SOPs, at all times.
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