Manager, Regulatory Affairs – Ad-Promo

This is a fully remote position, open to applicants in United States.

📋 Description

• Offer strategic, operational, and tactical regulatory counsel on advertising and promotional materials for both investigational and approved commercial products.

• Oversee the regulatory evaluation of advertising, promotional, disease awareness, training materials, campaigns, and product launch strategies.

• Assess materials for the U.S., Canada, Australia, the UK, Belgium, the Netherlands, Luxembourg, Spain, Germany, and additional markets outside the U.S.

• Act as the Regulatory Representative on the Materials Review Committee alongside Medical Affairs, Legal, and Marketing teams.

• Organize health authority submissions, including U.S. Form FDA 2253 submissions.

• Stay updated on U.S. promotional regulatory changes, FDA regulations, guidance, enforcement actions, and industry trends.

• Develop, maintain, and archive abbreviated Prescribing Information (aPI).

• Serve as the regulatory contact for global, regional, and local brand teams.

• Manage reviews of promotional and non-promotional materials outside the U.S. across key global markets.

• Assist affiliates with adherence to national and regional codes including EFPIA, ABPI, Farmaindustria, and AKG/IFPMA.

• Coordinate with external vendors and uphold standardized global review procedures.

• Build cross-functional relationships to facilitate compliant communication strategies.

• Recognize process enhancements, best practices, and tools for regulatory advertising and promotion efforts.

⛳️ Requirements

• A Bachelor's degree in life sciences, law, public policy, or a related discipline.

• At least 5 years of experience in pharmaceutical regulatory affairs, with a minimum of 2 years focused on regulatory advertising and promotion.

• Proven experience in reviewing U.S. advertising and promotional materials and completing Form FDA 2253 for U.S. submissions.

• Comprehensive understanding of pertinent international, national, and regional regulatory frameworks, processes, and requirements.

• Familiarity with Veeva PromoMats is preferred.

• Excellent communication skills.

• Capability to collaborate effectively with cross-functional stakeholders.

• Strong commitment to ethical practices.

• Flexibility to adapt in a dynamic work environment.

• Dedication to continuous learning and professional growth.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Competitive salary.