Head of Regulatory Affairs
July 19
Description
• Oversees all global regulatory strategy and operations planning for related activities • Directs the strategy (time, tone, and content) of interactions with the respective regulatory health authorities’ including the request, preparation and execution of meetings with regulatory authorities for product specific issue and policy related issues. • Develop and execute innovative regulatory strategies for each program’s drug development that can include multiple parallel disease indications, including obtaining global health authority designations to support expedited pathways. • Provides leadership in the design and execution of strategies for complex regulatory submissions in close collaboration with other company functions. • Stays informed of global regulatory requirements. • Acts as the liaison between FDA and other global health authorities • Compile and author documents for submission to regulatory agencies • Lead the authoring, review, approval, and submission process for IND and CTA submissions. • Play a key role in planning, preparation, drafting, and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA submissions, regulatory interactions, and responses to queries from competent authorities as required for the investigation and registration of drugs in the US and ex-US countries. • Ensure cross-functional alignment among stakeholders involved during key steps across multiple projects simultaneously
Requirements
• B.A./B.S. required; M.S., Ph.D., PharmD, MD, or other related advanced scientific degree strongly preferred • Over 10 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry. • Prior regulatory experience in drug development with demonstrated leadership of successful submissions to FDA (e.g., INDs, briefing packages, NDAs) and other regulatory agencies (e.g., EMA) • A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines. • Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena, including but not limited to the US. • Ability to build collaborative relationships both internally and externally. • Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers, and staff. • Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes
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