Remote Associate Dir, Medical Ad/Promo Regulatory Review

Regulatory Jobs; United States; 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 serve as an internal expert on FDA regulations, guiding promotional materials for complex products and coordinating with cross-functional teams from a remote US location.

You will mentor staff, chair review meetings, liaise with OPDP/APLB, and help ensure compliant, strategically aligned promotional content across assigned products.

Competenze

• Minimum 5 years’ experience in drug/biologic Regulatory Affairs or related field.
• At least 3 years in Regulatory Affairs – Advertising and Promotion.
• Extensive knowledge of regulations for promo of pharma/biologic products.
• Experience with major regulatory filings or enforcement letters.”
• Strong leadership and cross-functional collaboration skills.

Mansioni

• Serve as internal expert on FDA regulations, guidance, and enforcement trends for promotional materials.
• Chair promotional review meetings and support prioritization of materials.
• Act as liaison with OPDP/APLB reviewers for advisory comments and claims.
• Present regulatory topics to senior management and cross-functional teams.
• Maintain consistent review standards within the electronic approval system (EAS).

Conoscenze

Regulatory knowledge

Leadership

Cross-functional

Strategic thinking

Formazione

Life science degree

Advanced degree preferred

Strumenti

EAS system

Descrizione del lavoro

Takeda is seeking an Associate Director for US Medical Ad/Promo Regulatory Review. You will serve as an internal expert on FDA regulations, guiding promotional materials for complex products and coordinating with cross-functional teams from a remote US location.

You will mentor staff, chair review meetings, liaise with OPDP/APLB, and help ensure compliant, strategically aligned promotional content across assigned products.