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: DOE + Excellent Benefits Package Regulatory Professionals are working with a leading International pharmaceutical company who are looking for an Associate Director/Director to join their company. The successful applicant will be developing and leading regulatory strategies and initial registration plans for development, you will provide regulatory advice and expertise to research and commercial project teams. Main Responsibilities: * Provide regulatory expertise on current drug development and marketing authorisations requirements * Serve as the Regulatory Affairs lead representative on the project development * 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 regulatory affairs department at relevant external meetings, including global regulatory agency meetings, scientific and HTA advisory boards and trade association meetings. 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, scientific advice, Cambridgeshire, MAA, drug development, CNS, global, IND, CTA, Orphan drugs