Director, Global Regulatory Advertising & Labelling

Autolus Therapeutics; United States; Teletrabalho; USD 180 000 - 320 000; Tempo integral

Resumo da oferta

Autolus Therapeutics is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead regulatory activities for labeling and promotional communications across US/UK/EU. The role requires deep expertise in FDA OPDP, EU labeling standards, and global labeling governance.

You will guide cross-functional teams, drive compliant promotional content, and shape strategic labeling programs to support commercial objectives.

Qualificações

• Minimum of 15 years in pharma with at least 10 years in Regulatory Ad Promo
• Solid understanding of product labeling structure and function
• Strong ability to translate science into labeling content
• Knowledge of CCDS, USPI and EU SmPC requirements
• Experience guiding cross-functional labeling teams including senior management
• FDA promotional regulations and industry trends knowledge

Responsabilidades

• Develop regulatory strategy for advertising, promotion and medical communications
• Lead interactions with FDA OPDP/APLB for promotions and communications
• Oversee US promotional material review process and Veeva PromoMats implementation
• Ensure timely regulatory review and approval of US communications
• Collaborate with Commercial, Marketing, Legal, Compliance and others
• Provide regulatory training on FDA requirements and guidelines
• Lead global labeling strategy for TPLs, CCDS, USPI and SmPC
• Chair labeling governance to drive timely reviews and updates
• Deliver submission-ready labeling content for regulatory filings
• Mitigate labeling risks and resolve complex issues with leadership

Conhecimentos

FDA regulatory knowledge

Promotional claims assessment

Cross-functional leadership

Strategic labeling

Veeva PromoMats

Formação académica

BA/BS in a scientific discipline

Ferramentas

MS Office

Veeva PromoMats

Descrição da oferta de emprego

Autolus Therapeutics is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead regulatory activities for labeling and promotional communications across US/UK/EU. The role requires deep expertise in FDA OPDP, EU labeling standards, and global labeling governance.

You will guide cross-functional teams, drive compliant promotional content, and shape strategic labeling programs to support commercial objectives.