Manager, Regulatory Affairs (Ad-Promo)

Accountabilities: • Review advertising, promotional, disease awareness, and training materials to ensure compliance with applicable laws, regulations, internal policies, and commercial objectives.

• Support regulatory review activities across the United States, Canada, Australia, the United Kingdom, Belgium, the Netherlands, Luxembourg, Spain, Germany, and other international markets.

• Serve as the Regulatory representative on Materials Review Committees, collaborating with Medical Affairs, Legal, Marketing, and other stakeholders to assess regulatory risk and provide recommendations.

• Manage regulatory advertising and promotion activities for assigned products and serve as a regulatory point of contact for global, regional, and local brand teams.

• Coordinate health authority submissions for promotional materials in markets requiring pre-clearance or notification, including Form FDA 2253 submissions in the United States.

• Apply strong knowledge of FDA regulations, OPDP guidance, and requirements governing advertising and promotion of radiopharmaceutical products, escalating regulatory issues when appropriate.

• Monitor developments in the U.S. promotional regulatory landscape, including new FDA regulations, guidance, enforcement actions, and industry trends, and communicate relevant updates to stakeholders.

• Create, maintain, and store abbreviated Prescribing Information (aPI) in accordance with applicable regulatory expectations.

• Manage international promotional and non-promotional material reviews, ensuring alignment with local Prescribing Information, country-specific codes, regional requirements, and global standards.

• Support regional affiliates in interpreting and applying national and regional industry codes, including EFPIA, ABPI, Farmaindustria, and IFPMA-related requirements.

• Coordinate external vendors supporting global regulatory review activities, ensuring quality, accuracy, consistency, and adherence to timelines.

• Maintain efficient review processes through standardized templates, checklists, and workflows while identifying and escalating issues as needed.

• Build productive relationships with cross-functional stakeholders and identify process improvements, best practices, and tools that enhance the quality and efficiency of regulatory advertising and promotion activities.

Requirements

• Bachelor’s degree in life sciences, law, public policy, or a related field.

• Master’s degree or higher preferred.

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

• Demonstrated experience reviewing U.S. advertising and promotional materials and completing Form FDA 2253 submissions.

• In-depth understanding of relevant international, national, and regional regulatory frameworks, processes, and requirements.

• Working knowledge of Veeva PromoMats is desired.

• Strong written and verbal communication skills, with the ability to communicate clearly with stakeholders at different levels and across functions.

• Strong collaboration and stakeholder management skills, with the ability to build productive relationships across Marketing, Medical Affairs, Legal, Clinical, Commercial, Medical Information, and Public Affairs.

• Results-oriented approach with a strong commitment to quality, regulatory excellence, and measurable outcomes.

• Creative and solution-oriented mindset, with the ability to identify practical approaches to complex regulatory challenges.

• Resilience and adaptability in a dynamic environment with changing priorities and evolving regulatory requirements.

• Strong ethical standards, integrity, and commitment to inclusive and respectful collaboration.

• Commitment to continuous learning and ongoing professional development.

Benefits

• Competitive salary.

• Annual performance-based bonus opportunity.

• Equity-based incentive program.

• Generous vacation allowance.

• Paid wellness days.

• Learning and professional development support.

• Hybrid and remote work opportunities.

• Opportunity to work within a global, interdisciplinary environment focused on precision medicine, oncology, and rare diseases.

• Exposure to regulatory advertising and promotion activities across the United States and multiple international markets.

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