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.