The Director Regulatory Advertising and Promotion N.A is responsible for providing strategic and tactical regulatory ad promo support and guidance related to product and disease state communications for assigned product(s) or therapeutic area across the product life cycle.  As the internal subject matter expert on FDA regulations of prescription drug advertising and promotion, this role collaborates extensively with cross-functional teams to ensure that promotional communications are compliant and meet business objectives.   The incumbent will serve as the primary liaison with the FDA’s office of prescription Drug Promotion (OPDP) andThis role will report to the Global Head of Regulatory Advertising and Promotion and will have accountability for the review and approval of US promotional and non-promotional communications of assigned product(s). This experienced regulatory professional will contribute to the ongoing development of a best-in-class Regulatory Advertising and Promotion team.  This role is remote based on US Eastern time with limited travel to for business-critical meetings/events. Key ResponsibilitiesServe as lead regulatory reviewer for assigned product(s) on Sobi Review Committee (SRC) and as Regulatory Adpromo representative on relevant programs and other cross-functional teams.Review draft materials and collaborate with cross-functions including Medical, Legal and Marketing, etc to ensure that product and disease-state communications are compliant and impactfulProvide strategic direction and clearly articulate any potential risks in draft materials, along with sound rationales and anticipated likely outcomes.Partner with the business by providing alternatives to achieve business objectivesBuild and maintain strategic relationships with regulatory authorities- FDA, OPDP, ABLB to support Sobi business objectives.Proactively monitor and interpret monitor FDA enforcement actions and regulatory trends; assesses impact to support successful and compliant marketing of Sobi products.Assess the impact of proposed label wording or label changes on promotional strategy and provide input for label optimization as a member of the Label Working Group.Provide direction and work collaboratively to ensure that changes in product labeling are implemented in promotional materials in accordance with company procedures and regulatory requirements.Contribute to departmental and cross-functional efforts to develop and update applicable policies, procedures, guidelines and training.Responsible for a variety of tasks requiring sound judgment and independent initiative.Develop and conducts stakeholder training on matters pertaining to prescription drug promotion
