Global Director, Regulatory Affairs – Advertising & Labelling

Autolus Inc; Gaithersburg (MD); On-site; 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 and promotion strategy, ensuring compliance across the US/UK/EU.

You will partner with Commercial, Medical, Legal, and Compliance teams to deliver compliant material and submissions. The role requires deep regulatory expertise, strategic thinking, and hands-on leadership to drive timely reviews, SOP improvements, and cross-functional collaboration in a fast-paced biopharma setting.

Qualifications

• Minimum 15 years in the pharmaceutical industry with at least 10 years in Regulatory Ad Promo.
• Strong understanding of product labeling and CCDS, USPI and EU SmPC.
• Ability to guide cross-functional labeling teams and drive action plans.
• Excellent communication, presentation, and project management skills.
• Expert in FDA promotional regulations and global labeling requirements.

Responsibilities

• Develop global regulatory strategy for advertising, promotion and medical communications.
• Lead interactions with FDA OPDP/APLB and global labeling governance.
• Oversee material review processes and Veeva PromoMats implementation.
• Ensure timely regulatory reviews and approvals for labelling and promo content.
• Collaborate with Commercial, Marketing, Legal and Compliance teams.

Skills

Regulatory affairs

Advertising promotion

Labelling

Veeva PromoMats

Project management

Cross-functional leadership

FDA regulations

Education

BA/BS in scientific discipline

Advanced degree preferred

Tools

MS Office

Adobe Acrobat

Job description

Autolus Inc. is seeking a Director of Regulatory Affairs Advertising, Promotion & Labelling to lead global labeling and promotion strategy, ensuring compliance across the US/UK/EU.

You will partner with Commercial, Medical, Legal, and Compliance teams to deliver compliant material and submissions. The role requires deep regulatory expertise, strategic thinking, and hands-on leadership to drive timely reviews, SOP improvements, and cross-functional collaboration in a fast-paced biopharma setting.