Regulatory Affairs Director

Regulatory Professionals
United Kingdom
On Application
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affairs Director Location: Hertfordshire Competitive salary + Bonus & Car allowance Employment: Permanent Ref: J29783 Our Client is a global pharmaceutical business with over 70 years' experience in drug development. They are researching, studying, manufacturing and making society aware of the benefits of a new drugs. They are working across the globe in many different therapy areas and are now developing new portfolio in Europe. They are looking for an exceptional individual with broad experience within Regulatory Affairs to work on range of tasks in the Oncology department. Responsibilities: * To implement and develop regulatory strategy * To develop and deliver complete regulatory submissions within agreed timeframes * To plan, execute and assess product life cycle management activities and strategies * To contribute to implementing a strategy for interactions and negotiations with Health Authorities and handle routine communication with authorities * To manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines * To manages team finances in compliance with financial standards and guidelines * To manage all employee-related activities throughout the year, including performance management and development Requirements: * Strong drug development background * Experience developing regulatory strategies * Oncology experience is a must * Line Management experience * Life science degree * EU market experience as a minimum, US is highly desirable : Regulatory Affairs, RA, Emerging Markets, MAA, Marketing Authorization Application, US, London, Hertfordshire, strategy, Senior Manager, Associate Director, CMC, life cycle, NDA