Associate Director/Director, Strategic Regulatory Affairs

Regulatory Professionals
East Horsley
29 Sep 2017
03 Nov 2017
Contract Type
Full Time
Associate Director/Director, Regulatory Affairs Strategy Location: Cambridge Salary: DOE + Excellent Benefits Package Job Reference: J30856 Clinical Professional's Regulatory team are currently working with an industry leading, International pharmaceutical company. Our client is looking for a driven Associate Director/Director to join them; you will be responsible for enhancing and guiding regulatory strategies, as well as providing regulatory expertise to their project teams. The main responsibilities that this role entails are as follows: * Provision of regulatory advice and knowledge on current drug development, as well as authorisation requirements. * You will be the Regulatory Affairs lead representative on the project throughout its development. * Develop the strategic regulatory plan for each assigned project. * Ensure any CTAs/INDs, MAAs/NDAs, orphan drug designation and scientific advice applications are submitted in a timely fashion. * Improve quality of regulatory strategies and promotion of drug development. * Be the representative at the regulatory affairs department global regulatory agency meetings, scientific and HTA advisory boards and trade association meetings. The ideal applicant will possess the following qualifications and experience: * Must have achieved a Science degree or equivalent. * Profound experience of the biotech and pharmaceutical industry. * Extensive knowledge of drug development and approval requirements. * Ideally have experience in pain or CNS therapeutic areas. * Must have overseen multiple drug development submissions and approvals, including CTA/INDs and MAA/NDAs. * Global market experience. In addition to the above, a ‘self-starter' attitude and definite strategic mind-set is highly desired, as well as an ability to effectively work with a team to motivate and promote excellence. Our client offers a brilliant set of benefits to the successful applicant, including a 28% flexible salary bonus. 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 placed 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, project management, leadership, Bedfordshire, Hertfordshire, Norfolk