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Job Location | London |
Education | Not Mentioned |
Salary | Salary negotiable |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
Permanent Regulatory Affairs Manager Life cycle maintenance MA Transfers EU Markets Project Management Your new companyA pioneering niche pharmaceutical company currently undergoing rapid expansion, owning & commercialising one of the worlds leading multi-million-pound IVF products. There are many opportunities for personal & career development in this fast-growing company.We place great emphasis on developing staff & strongly believe in an open, empowered friendly team culture. We work closely with the medical profession, leading healthcare professionals and international commercial partners to ensure outstanding service andquality. Your new roleRenewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK which involves liaising with CMOs and third-party service providers for required documents on regular basis. Workingalongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines, and conditions in these markets. What youll need to succeed* Knowledge of EU DCP/National and lifecycle maintenance* Authoring & preparation of regulatory packages and documents for submissions * Direct, hands-on experience of MA transfers * Reviewing/annotating and approving artworks and labelling * Knowledge of EU, Asia and MENA regulations and post approval proceduresWhat youll get in return25 days holiday, Market Leading salary, Hybrid working model and the opportunity to excel in a unique environment, making a difference daily, with a fun and rewarding role.What you need to do nowIf youre interested in this role, click apply now to forward an up-to-date copy of your CV, or call us now.If this job isnt quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.