Global Regulatory Labelling & Promotion Director

Autolus Inc; New Jersey; Ibrido; USD 180.000 - 240.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive salary

Private medical insurance

Pension

Descrizione del lavoro

Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global regulatory activities for product labeling and promotional materials in the US, UK, and EU.

You will shape strategy, oversee processes, and ensure regulatory compliance across cross-functional teams. The role requires deep knowledge of US FDA promotion rules, labeling standards, and international health authority expectations, with a focus on enabling compliant, impactful communications for

Competenze

• 15+ years in pharmaceutical industry with at least 10 years in regulatory advertising/promotional roles
• Strong understanding of labeling content and regulatory expectations for US/UK/EU
• Experience with FDA OPDP and global advertising regulations
• Ability to lead cross-functional teams and communicate complex regulatory concepts effectively
• Proven ability to develop and implement labeling and promotional strategies

Mansioni

• Develop and implement regulatory strategy for advertising, promotion, and medical communications
• Lead interactions with FDA OPDP/APLB and other global health authorities
• Oversee labelling governance, USPI/SmPC/CCD S and core labelling documents
• Lead Veeva PromoMats implementation and related process improvements
• Collaborate with Commercial, Legal, Medical and Compliance to align regulatory requirements with business goals
• Provide regulatory training and mentoring to cross-functional teams
• Identify labeling risks and develop mitigation plans
• Participate in submission planning and health authority responses

Conoscenze

Regulatory strategy

FDA/OPDP knowledge

Regulatory communications

Cross-functional leadership

Strategic labeling

Formazione

BA/BS in scientific discipline

Advanced degree preferred

Strumenti

Veeva PromoMats

Descrizione del lavoro

Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global regulatory activities for product labeling and promotional materials in the US, UK, and EU.

You will shape strategy, oversee processes, and ensure regulatory compliance across cross-functional teams. The role requires deep knowledge of US FDA promotion rules, labeling standards, and international health authority expectations, with a focus on enabling compliant, impactful communications for