Autolus Therapeutics

Compliance

• Develop and implement regulatory strategies for advertising, promotion, and medical communications
• Lead interactions with FDA OPDP/APLB regarding promotional and medical communications
• Interpret applicable regulatory guidance, regulations, and precedents
• Support and implement the Promotional and Medical Communications Material Review Process using Veeva PromoMats
• Advise on compliant product messages and materials across functional areas
• Lead timely regulatory review and approval of US promotional and medical communications
• Contribute to material review meetings
• Prepare and submit regulatory documents, including Form 2253, to OPDP/FDA
• Collaborate with Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and other stakeholders
• Foster regulatory compliance and excellence
• Provide training on FDA requirements, PhRMA DTC Guidelines, and the company materials review process
• Lead global labelling strategy and development for assigned products, including TPLs, CCDS, USPI, SmPC, and related core labelling documents
• Serve as global labelling subject matter expert
• Chair cross-functional labelling governance processes
• Ensure global, regional, and local labelling remains aligned and compliant with clinical, safety, and manufacturing data
• Partner with Regulatory Affairs, Supply Chain, Manufacturing, and other functions on submission-ready labelling and regulatory filings
• Identify and mitigate labelling risks and resolve complex labelling issues
• Develop strategic responses to labelling-related Health Authority questions
• Create, improve, and update departmental or cross-functional processes and SOPs
• Attend occasional domestic and international business-critical meetings/events

Explore Director, Regulatory Affairs – Advertising, Promotion and… at Autolus Therapeutics. Review requirements and application details.

Director, Regulatory Affairs – Advertising, Promotion and Labelling