Executive Director, Regulatory Strategy
Automatic Data Processing, Inc.Orporated
Washington, District of Columbia, United States
Job type: fulltime
Job industry: Executive Positions
The Executive Director, Regulatory Strategy is responsible for providing leadership, therapeutic area knowledge and strategic guidance in all regulatory aspects for all assigned products/projects.. The Executive Director, Regulatory Strategy will report to the Sr VP Regulatory Affairs This individual will provide leadership and direction for regulatory activities, including preparation of INDs, NDAs, Health Authority Meeting Requests and Associated Briefing Documents, Special Development Designations, e.g., Orphan Designation, Fast Track Designation, etc. This individual will have the proven ability to adhere to ethical and good regulatory practices; the ability to work as part of a team, both in a leadership role and as a contributing member of the company. He/she will possess strong interpersonal skills and the ability to work collaboratively, and will be an effective communicator and public speaker, with excellent written and verbal communication and presentation skills.. Specifically, the position incumbent will:. Provide US, EU and/or global strategic input and coordination of regulatory strategy. Represent regulatory as the global lead representative in the Core Product Teams,. May serve as backup for Sr VP Regulatory Affairs, as appropriate. May serve as delegation head for health authority meetings. Oversees the assembly, review and approval of all regulatory dossiers and documents (content) and the final sign-off of regulatory submissions for assigned products/projects.. Predicts health authority questions and objections and addresses them prospectively in the dossier (or manages them promptly) to achieve approval with minimal delays. Provides strategic input to target labeling (Company Core Data Sheet, SmPC, US Package Insert, container packaging, etc.) content.. Serves as regulatory representative on the Promotional Review Committee for assigned products/projects. Provides strategic input to product lifecycle issues.. Provides Due Diligence support for merger, acquisition, partnering and licensing activities for assigned products/projects.. Works closely with and coordinates project related activities of Regulatory Managers, Regulatory Operations, Regulatory CMC and Medical Writing staff to ensure appropriate regulatory support for products/projects. Develops relationships with other regulatory professionals, associations and authorities. Checks conformity of press releases, external communications and advertisements, as appropriate. May serve as representative on Industry groups/task forces. Collects and analyses information of regulatory and competitive environment and shares with Regulatory Affairs and other groups as appropriate. REQUIRED EDUCATION/EXPERIENCE/SKILLS:. MD or Ph.D. degree in a science-related field or equivalent relevant experience. At least 8 years of regulatory experience, including 5 years in a strategic role involving direct interactions with Health Authorities. 10 years of combined drug development/regulatory experience, project management and/or regulatory submissions experience. Demonstrated track record of regulatory approvals in major markets. Ability to think 'analytically as well as strategically' with the ability to convey complex concepts in an understandable manner. Ability to develop and implement creative approaches to ensure regulatory success. Ability to work successfully in a 'team-based' environment. Ability to understand, manage and lead in a multi-cultural atmosphere. Proven leadership, project management, development of people, and process improvement abilities. Excellent interpersonal communications, organizational, and presentation skills. Superior negotiation and influencing skills. BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.. The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
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