Global Regulatory Lead Advertising, Promotion & Labelling

Autolus, Inc.; New Jersey; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Autolus, Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling strategy, regulatory promotions review, and cross-functional governance across US/UK/EU.

You will shape strategic labeling content for products and pipelines, collaborate with Commercial, Medical Affairs, Legal, and Manufacturing, and ensure alignment with FDA, UK, and EU requirements. Ideal candidates have extensive experience in regulatory Ad Promo, labeling, and global

Qualifications

• 15+ years in pharmaceutical industry with at least 10 years in Regulatory Ad Promo
• Strong understanding of product labeling structure and FDA/OPDP guidelines
• Experience with CCDS, USPI, and EU SmPC labeling considerations

Responsibilities

• Lead global regulatory promotional and medical communication strategy for US/UK/EU.
• Oversee development of Promotional and Medical Communications material review processes and SOPs.
• Provide regulatory interpretations and ensure timely approvals of US promotional materials.
• Collaborate with Commercial, Legal, and Compliance to align regulatory requirements with business needs.

Skills

Regulatory strategy

Advertising & Promotion

Labelling expertise

Cross-functional leadership

Veeva PromoMats

FDA/OPDP knowledge

Education

BA/BS in a scientific discipline

Tools

Veeva PromoMats

MS Office

Job description

Autolus, Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling strategy, regulatory promotions review, and cross-functional governance across US/UK/EU.

You will shape strategic labeling content for products and pipelines, collaborate with Commercial, Medical Affairs, Legal, and Manufacturing, and ensure alignment with FDA, UK, and EU requirements. Ideal candidates have extensive experience in regulatory Ad Promo, labeling, and global