job details for:
Regulatory Affairs - Manager International Regulatory Affairs Jobs - London

Regulatory Affairs - Manager International Regulatory Affairs Jobs - London (Job Ref: WR/JOBS/26011-12348)

Job Description :

Flame Pharma - Regulatory Affairs - Manager International Regulatory Affairs Job - London

London, UK:  Excellent salary, plus Bonus, Pension, Stock Options, Healthcare

Flame Pharma is working alongside a global biopharmaceutical organisation at the forefront of developing new medicines in areas where the need is currently unmet.  This pioneering company has an impressive portfolio of products in anti-viral, cardiovascular and respiratory therapeutic areas.   As a result of expansion within their offices in London, UK, we are working on a recruitment project to source a Manager International Regulatory Affairs to be responsible for the preparation of regulatory submissions for investigational and commercial HIV medicinal products.

The Role:

This position will report to the Director for HIV in International Regulatory Affairs and will be responsible for the preparation of regulatory submissions for investigational and commercial HIV medicinal products.  The Manager of International Regulatory Affairs will prepare and co-ordinate the preparation of  non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the marketing Authorisation Holder via the European Centralised procedure, e.g. renewals, variations, responses to questions, Follow-up Measures , PSURs etc. The successful candidate will be responsible for ensuring product packaging and associated information is updated and maintained in accordance with Marketing Authorisations including the review and provision of accurate labeling translations.  They will also prepare regulatory documentation to support Clinical Trial Applications and amendments for investigational medicinal products.

The Person:

A degree in biological/life sciences, pharmacy or medicine is required.  Maintenance / Centralised process and Post marketing experience in Regulatory Affairs is essential, plus you must have an appreciation of the coordination required for translations across an EMEA territory.  Experience representing Regulatory Affairs on project teams is also required, plus experience of working with Regulatory Authorities in Europe

Key Words:

Regulatory Affairs, Manager International Regulatory Affairs, Anti-infectives, HIV, Virology, Regulatory Affairs Director, Drug Safety, PV, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Drug Safety, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, London, Biotechnology, Biopharmaceutical

For further information and to apply for this role, please contact Flame Pharma today on 0800 085 0858.