job details for:
Regulatory Affairs - Regulatory Affairs Director Jobs - London

Regulatory Affairs - Regulatory Affairs Director Jobs - London (Job Ref: WR/JOBS/25685-12043)

Job Description :

Flame Pharma - Regulatory Affairs – Regulatory Affairs Director Job – London

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 Director of Regulatory Affairs with proven ability over a substantial period in managing and developing Regulatory Affairs professionals working across functions and geographies, building effective business relationships.

The Role:

The successful candidate will oversee progression of all regulatory activities in the company portfolio of products including submission of centrally prepared documentation to national Regulatory Authorities as needed to obtain and maintain licenses for company products and clinical trial applications for development products. They will ensure compliance with national GMP/GDP requirements and support for product complaints.  The Regulatory Affairs Director will work in cooperation with the Qualified Person Pharmacovigilance (QP PV) ensuring that all the pharmacovigilance activities are undertaken.  The candidate will lead, manage, support and mentoring direct reports with overall responsibility for a growing team of regulatory professionals.

The Person

The Regulatory Affairs Director must have proven, extensive regulatory affairs experience in a pharmaceutical, biotechnology or clinical research organisation.  They will have a well developed scientific and analytical knowledge base, with an in-depth understanding of current regulations The ability to line manage and develop a team of regulatory affairs professionals is also essential.

Key Words

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

For more information and to apply for this position, please call Flame Pharma today on 0800 085 0858.