Director, Regulatory Affairs – Advertising, Promotion and Labelling

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Create and execute regulatory strategies for advertising, promotion, and medical communications.

• Lead communications with FDA OPDP/APLB concerning promotional and medical communications.

• Analyze relevant regulatory guidance, regulations, and precedents.

• Assist and manage the Promotional and Medical Communications Material Review Process utilizing Veeva PromoMats.

• Provide guidance on compliant product messaging and materials across different functional areas.

• Oversee the timely regulatory review and approval of US promotional and medical communications.

• Participate in material review meetings.

• Prepare and submit regulatory documents, such as Form 2253, to OPDP/FDA.

• Collaborate with Commercial, Marketing, Medical Affairs, Legal, Compliance, Regulatory Affairs, and other stakeholders.

• Promote regulatory compliance and excellence.

• Conduct training on FDA requirements, PhRMA DTC Guidelines, and the company materials review process.

• Direct global labeling strategy and development for assigned products, including TPLs, CCDS, USPI, SmPC, and related core labeling documents.

• Act as the global labeling subject matter expert.

• Chair cross-functional labeling governance processes.

• Ensure that global, regional, and local labeling is consistent and compliant with clinical, safety, and manufacturing data.

• Collaborate with Regulatory Affairs, Supply Chain, Manufacturing, and other functions on submission-ready labeling and regulatory filings.

• Identify and mitigate labeling risks while resolving complex labeling issues.

• Develop strategic responses to labeling-related Health Authority inquiries.

• Create, enhance, and update departmental or cross-functional processes and SOPs.

• Attend occasional domestic and international business-critical meetings/events.

⛳️ Requirements

• A minimum of 15 years of experience in the pharmaceutical industry.

• At least 10 years of experience as a Regulatory Advertising and Promotion professional.

• A minimum of 6 years of strategic labeling experience.

• Comprehensive understanding of the structure and function of product labeling.

• Strong scientific background with the ability to interpret scientific documents and concepts.

• Knowledge of global standards and regulations related to CCDS and product labeling.

• USPI and EU SmPC experience is mandatory.

• Capability to guide cross-functional labeling teams, including senior management.

• Familiarity with medical concepts and terminology.

• Advanced understanding of FDA promotional regulations, industry trends, regulatory landscapes, products, therapeutic knowledge, and evidentiary standards for product claims.

• Proven business acumen and understanding of company objectives.

• Demonstrated ability to identify issues and formulate risk mitigation strategies.

• Excellent oral and written communication, project management, and presentation skills.

• Ability to negotiate effectively and address disagreements in a constructive manner.

• Proven track record of managing critical issue situations with efficacy.

• Expertise in Veeva PromoMats.

• Strong computer skills, including proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Teams, and Adobe Acrobat.

• BA/BS in a scientific discipline.

• Must be located in US-New Jersey (Remote).

🏝️ Benefits

• Flexible, diverse, and dynamic working environment.

• Inclusive and equitable workplace.

• Reasonable accommodations provided throughout the recruitment process.

• Commitment to professional development and investment in employees.

• Opportunities for occasional domestic and international business travel.