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Years of Experience
ProfileAssoc Director, US Ad/Promo Regulatory Review, GI (USBU)
Qualification and Experience
The candidate should have Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred. Should have 5+ years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including 3+ years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered. Extensive knowledge of applicable regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products for healthcare professionals, payor and consumer audiences. Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) or competitor complaints. Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams. Provide leadership related to issues of critical importance; provide regulatory advice and recommendations involving regulatory issues on topics for which there may not be clear/specific regulatory insights. Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed. Maintains current knowledge of applicable government regulations, particularly those related to advertising and promotion, including key global codes of practice and regulations. Has thorough knowledge of historical enforcement actions and is readily able to use this when offering recommendations to stakeholders. Excellent oral and written skills, timeline responsibilities, negotiations skills. Works well with others, especially on a cross-functional team, direct reports and senior leadership. Prior leadership of individuals/team preferred. Demonstrated leadership skills. Ability to effectively manage and bring working teams together for common objectives. Models leaders at all levels daily.Should have Regulatory Affairs Certification (RAC) desirable. Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
Takeda Pharmaceutical Company Limited.
One Takeda Parkway
Deerfield, IL 60015