Director, Regulatory Affairs – Advertising, Promotion and Labelling
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Job Description
Regulatory affairs director guiding FDA-compliant promotion, medical communications, and global labelling for Autolus cancer and autoimmune therapies. Leading cross-functional strategies, reviews, submissions, and governance.
Responsibilities:
- 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
Requirements:
- Minimum of 15 years of experience in the pharmaceutical industry
- At least 10 years as a Regulatory Advertising and Promotion professional
- At least 6 years of strategic labelling experience
- Solid understanding of the structure and function of product labelling
- Strong scientific background and ability to interpret scientific documents and concepts
- Knowledge of global standards and regulations related to CCDS and product labelling
- USPI and EU SmPC experience required
- Ability to guide cross-functional labelling teams, including senior management
- Understanding of medical concepts and terminology
- Advanced understanding of FDA promotional regulations, industry trends, regulatory landscape, products, therapeutic knowledge, and evidentiary standards for product claims
- Demonstrated business acumen and understanding of company objectives
- Proven ability to identify issues and develop risk mitigation strategies
- Excellent oral and written communication, project management, and presentation skills
- Ability to negotiate persuasively and address disagreements constructively
- Track record of handling critical issue situations effectively
- Expert in Veeva PromoMats
- Strong computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat
- BA/BS in a scientific discipline
- Must be based in US-New Jersey (Remote)
Benefits:
- Flexible, diverse and dynamic working environment
- Inclusive and fair workplace
- Reasonable accommodations throughout the recruitment process
- Professional development and investment in people
- Occasional domestic and international business travel opportunities
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