Senior Manager Regulatory Advertising and Promotion

The Senior Manager, Regulatory Advertising and Promotion, N.A. will be responsible for ensuring that product and disease communications comply with applicable laws, regulations, Sobi policies, and regulatory requirements for both promotional and non-promotional materials related to assigned product(s). Reporting to the Global Head of Regulatory Advertising and Promotion, this role will serve as the primary regulatory reviewer on the Sobi Review Committee(s) for promotional and non-promotional materials. The incumbent will provide strategic regulatory guidance based on a strong understanding and sound interpretation of FDA regulations, guidance documents, OPDP/APLB precedents, and industry best practices.This position requires frequent interaction and strong collaboration with cross-functional partners, including Legal, Medical, Compliance, Marketing, Labeling, and other teams, to develop strategies and implement tactics for compliant communications that align with Sobi’s corporate and brand objectives.This is a remote role with occasional travel to Sobi sites for business-critical meetings and events.Key ResponsibilitiesServe as the primary regulatory reviewer for assigned product(s) on the Sobi Review Committee (SRC).Review materials, provide real-time regulatory risk assessments, and recommend mitigation strategies.Collaborate with cross-functional teams—including Medical, Legal, and Commercial—to ensure that product and disease-state communications meet regulatory requirements.Monitor the external environment to keep product teams informed of evolving regulatory requirements related to advertising and promotion, and assess potential impacts on marketing activities.Plan and deliver training to internal stakeholders on U.S. laws, codes, and regulations related to drug advertising and promotion.Provide input into label development with consideration of promotional implications, including the evaluation of potential labeling claims.Ensure changes in product labeling are implemented into promotional materials in accordance with company procedures and regulatory requirements.Represent Regulatory Advertising and Promotion on cross-functional project teams and other relevant programs as needed.Collaborate with cross-functional teams to optimize the material review process.