Senior Regulatory Manager, Oncology

Key People Limited
40,000 - 60,000
07 Oct 2017
05 Nov 2017
Contract Type
Full Time
An excellent opportunity has arisen for a Senior Regulatory Manager, International Strategy, to join a growing Biopharma client based in Oxfordshire on a permanent basis. Within this role you will be responsible for ensuring the quality of regulatory input and implementation for product development and life cycle management. You will also contribute to the global expansion of the company’s marketed products and oversee select International regulatory projects, ensuring timely registration of products in compliance with applicable regulations and guidance. You will also be responsible for the implementation of regulatory strategies through coordination and preparation of submission documents for the registration of new products. Essential Functions• Creates, evaluates, and completes International regulatory projects consistent with the company goals. The successful candidate is responsible for assembling regulatory submissions and international dossiers to non-EU territories• Develop and implement regulatory strategies to facilitate the progress of global expansion of the company’s marketed products • Serve as the Regulatory Affairs representative on internal and external project teams; assuring the progression of projects by providing strategy• Work with project-specific subject matter experts to successfully interact with international partners and global health authorities, including meeting preparation and communication of commitments and meeting outcomes • Manage meetings with marketing partners, and vendors for products/projects• Maintain awareness of and communicate within the organization changing requirements across the international regulatory landscape (especially with respect to non-EU, emerging markets), updates for regulatory intelligence, and provide regulatory training• Represent the company in external forums• May manage and/or mentor junior regulatory professionalsRequired Knowledge, Skills, and Abilities • Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals• Previous experience with global regulatory filings (i.e. Canada, EU, Middle East, Asia-Pacific and South/Central America)• Proven track record of effective collaboration with third parties/partners and regulatory agencies to obtain market clearance in other countries• Demonstrated success in management of regulatory activitieso Experience with regulatory agencies and preparation of documentation to support interactionso Ability to lead health authority interactionso Knowledge and experience in preparation of global regulatory strategies o Experience with maintenance of regulatory authorizations and variations in at least two regionso Experience working on cross-functional development teams (including Commercial and R&D personnel)• Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions• Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others• Excellent verbal and written English and communication skills• Some travel required