Director, Regulatory Affairs Advertising & Promotion

This position is remote, but candidates must live on the US East Coast. #LI-remote Key ResponsibilitiesServe as an internal subject matter expert on FDA Advertising & Promotion issues, including scientific exchange, for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional and non-promotional materials to maintain compliance with applicable regulationsProvide regulatory training as needed on applicable laws, regulations and Sobi policies, and leadership on assigned RC with respect to best practices in compliance with company policies and guidelines for RC processes. Demonstrate leadership as the regulatory reviewer on RC(s)Manage interactions with OPDP/APLB, including response to regulatory inquiries, and as needed, discussion with OPDP/APLB staffFoster a healthy business partnership environment with stakeholders to ensure company meets strategic business objectivesPartner with RC teams in the management of tasks that help support compliant execution of tactics and programs through the product’s life-cycleExperienceMinimum of 10 years of experience in pharmaceutical industry and a minimum of 5years as a Regulatory Ad & Promo professionalExperience in Rare Diseases; Hematology and/or Oncology a plusAdvanced knowledge of U.S. advertising promotion regulations and scientific exchange provisions with proficient technical knowledge in aspects of drug development and labellingAdvanced experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion mattersExperience with international regulatory advertising and promotion regulations and processes a plus but not requiredCore CompetenciesAdvanced understanding of FDA promotional regulations, industry trends, regulatory landscape, product and therapeutic knowledge as well as evidentiary standards required to support product claimsApply advanced regulatory experience and business knowledge in the development of new ideas and best practices that support SobiAdvanced ability to spot issues and convey facts and risk mitigation strategies and guidance, including impact to Sobi without sufficient risk mitigationDemonstrate understanding of company objectives while executing regulatory strategies that deliver compliant, compelling, and timely work productMust reasonably foresee situations that are likely to be vague or challenging, and strategize to prevent or mitigate negative impactDemonstrate the ability to build agreement and acceptance through the ability to present a compelling case for ideas, negotiate persuasively, and address disagreements constructivelyEfficiently and systematically plan, prioritize, and execute individual work, team work, and projects while balancing quality, risk, and benefitsThe base salary pay range for this role is $170,000-$220,000 annually. Actual pay for this position will take into account factors such as experience and location. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin.