Remote Associate Director, Medical Ad/Promo Regulatory

Takeda; Boston (MA); Remoto; USD 154.000 - 243.000; Tempo pieno

Descrizione del lavoro

Takeda is seeking an Associate Director for US Medical Ad/Promo Regulatory Review. You will act as an internal expert on FDA regulations and enforcement trends that govern promotional materials for prescription products.

The role includes regulatory oversight for complex products and leadership of promotional review meetings, reporting to the Director, US Medical Ad/Promo Regulatory. This remote position requires cross-functional collaboration, strong leadership, and the ability to mentor staff

Competenze

• Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
• Ideal candidate has a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion.
• 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) or enforcement actions.
• Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
• Leadership experience and ability to manage teams and priorities in a matrix environment.
• Understanding of clinical development phases and regulatory review processes.
• Maintains current knowledge of applicable government regulations and enforcement actions.

Mansioni

• Collaborate with Regulatory Affairs, Medical, Legal, Commercial, and Compliance to review and approve key campaigns.
• Serve as an internal expert on FDA regulations and enforcement trends governing promotion of products.
• Lead regulatory strategy discussions and provide risk mitigation recommendations.
• Present regulatory topics to senior management and cross-functional teams.
• Liaise with OPDP/APLB reviewers for advisory comments and promotional claims.
• Attend team meetings and share learnings from FDA advisories and enforcement actions.
• Oversee internal promotional review processes and improve efficiency.

Conoscenze

FDA regulations

Regulatory strategy

Leadership

Cross-functional

Promo reviews

Formazione

Life science degree

Advanced degree preferred

Descrizione del lavoro

Takeda is seeking an Associate Director for US Medical Ad/Promo Regulatory Review. You will act as an internal expert on FDA regulations and enforcement trends that govern promotional materials for prescription products.

The role includes regulatory oversight for complex products and leadership of promotional review meetings, reporting to the Director, US Medical Ad/Promo Regulatory. This remote position requires cross-functional collaboration, strong leadership, and the ability to mentor staff