Director, Regulatory Advertising and Promotion N.A. Job at Sobi - Swedish Orphan

Director, Regulatory Advertising and Promotion N.A. Position overview: 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). This role is remote based on US Eastern time with limited travel for business‑critical meetings/events. Key Responsibilities Serve as lead regulatory reviewer for assigned product(s) on Sobi Review Committee (SRC) and as Regulatory Adpromo representative on relevant programs and cross‑functional teams. Review draft materials and collaborate with cross‑functions including Medical, Legal and Marketing to ensure that product and disease‑state communications are compliant and impactful. Provide strategic direction and clearly articulate potential risks in draft materials, with rationales and anticipated outcomes. Partner with the business by providing alternatives to achieve objectives. Build and maintain strategic relationships with regulatory authorities—FDA, OPDP, ABLB—to support Sobi objectives. Proactively monitor and interpret FDA enforcement actions and regulatory trends; assess impact for compliant marketing. Assess impact of proposed label wording/label changes on promotional strategy and provide input as a member of the Label Working Group. Ensure 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. Take responsibility for tasks requiring sound judgment and independent initiative. Develop and conduct stakeholder training on prescription drug promotion. Qualifications Education Required: Minimum Bachelor’s Degree in a scientific or healthcare‑related field with at least 10 years of related biopharma experience. Preferred: Advanced scientific degree (MD, PharmD, PhD) or Juris Doctor with a minimum of 8 years related biopharma experience. Experience and Skills Minimum of 8 years of regulatory experience in the pharmaceutical industry and a minimum of 5 years of regulatory AdPromo experience. Expert knowledge of FDA prescription drug regulations, policies, guidances, and enforcement trends. Experience supporting product launch; DTC broadcast ads experience highly desirable. Ability to advise key stakeholders on complex adpromo compliance issues. Strong leadership skills and ability to collaborate across all levels. Good understanding of clinical study design and statistical analyses for promotional claims. Understanding of drug development and labeling. Experience in Rare Diseases, Immunology, and/or Hematology a plus. Strong interpersonal and communication skills; able to lead with or without direct authority. Foster a culture of compliance, innovation, accountability, and continuous learning. Ability to innovate, analyze, and solve problems. Compensation and Benefits The base salary range for this role is 175,000 – 235,000 . Each individual offer will be determined based on experience, qualifications, and location. This role is eligible for short‑term and long‑term bonuses as outlined in the plan details. Additional benefits include: Competitive 401(k) match. Tuition and wellness reimbursements. Comprehensive medical, dental, and vision package. Additional recognition awards. Why Join Us? We are a global company with over 1,700 employees in more than 30 countries, committed to improving the lives of patients with rare diseases. We offer a collaborative, team‑oriented environment that emphasizes work/life balance, continuous learning, and impact on patients’ lives. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex, age, disability, sexual orientation, gender identity, protected veterans, marital status, or any other status protected by laws or regulations. COVID-19 Policy All new hires in the U.S. must be fully vaccinated for COVID‑19 with proof. Reasonable medical or religious accommodations and state‑specific exemptions will be considered as required by applicable law. #J-18808-Ljbffr