Regulatory Affairs Director - Oncology

Regulatory Professionals
On Application
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affairs Director - Oncology Full time, permanent position Hertfordshire, UK Ref: J30461 Regulatory Professionals are working with a leading research based pharmaceuticals company that work across the healthcare sector. They are looking to recruit a Regulatory Affairs Director to lead their oncology portfolio for the EU. This company pride themselves in their ethical standards across their range of business activities and emphasise the importance of patient health and well-being, by discovering and developing innovative medicines worldwide. Job Description: * Manage and co-ordinate requests for scientific advice with regulatory agencies in the EU and prepare briefing packages * Direct regulatory strategy and contribute to the outcome of assigned projects * Provide strategic input into product lifecycle manage plans and maintain licences for markets products * Provide input into clinical development plans * Support regulatory strategy and manage timelines and resources * Manage a team of 3 and train new staff members Application Requirements: * In depth knowledge of the EU Clinical Trials Directive * Experience of the drug development process and collaborating with international teams * Line Management experience is highly beneficial * Experience working on Oncology products * Experience of providing input into clinical development plans * Thorough knowledge and experience of submissions made through the Centralised Procedure Regulatory, Director, Associate, London, Hertfordshire, Essex, Cambridge, Luton, Buckinghamshire, Bedfordshire, Clinical, Development, Strategy, EU, US, MRP, DCP, Oncology, Affairs