Associate Director/Director, Strategic Regulatory Affairs

Regulatory Professionals
East Horsley
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Associate Director/Director, Strategic Regulatory Affairs Location: Cambridge Salary: Very competitive base salary and flexible benefits package Job Ref: J30733 Regulatory Professionals are working with a well-established and respected pharmaceutical company who are looking for an Associate Director or Director to join their company. This role will provide regulatory advice and expertise to research and development and commercial project team counterparts. The company provide strategic support to pharma and biotech companies on a global scale and has a network stretching across over 50 companies worldwide. Main Responsibilities: * Optimise drug developments and initial drug registration by providing regulatory expertise * Serve as the Regulatory Affairs lead representative on the project development asset team * Develop the strategic regulatory plan for assigned project(s) * Ensure timely delivery of CTAs/INDs, MAAs/NDAs, orphan drug designation, scientific advice applications * Undertake due diligence activities as requested and provide critical regulatory assessment and recommendations to influence decision making * Improve quality of regulatory strategies, panning and promoting function of strategic drug development * Represent the company both internally and externally Application Requirements: * Science degree or equivalent * Extensive regulatory experience in the biotech and pharmaceutical industry * In-depth knowledge of drug development and approval requirements * Experience in pain or CNS therapeutic areas * Proven record of overseeing multiple high standard drug development submissions and approvals, including CTA/INDs and MAA/NDAs * Global market experience dealing with a broad range of health authorities such as EMA, FDA, MHRA, TGA and others * Strong strategic regulatory mind set and ability to build relationships and inspire confidence and respect Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice. regulatory, strategy, advice, Cambridgeshire, MAA, drug development, CNS, global