Full-Time Senior Manager Regulatory Advertising and Promotion

• Serve 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.

• Minimum of a Bachelor’s degree in a scientific discipline required
• Advanced scientific degree (e.g., MS, PharmD, PhD, MD) preferred
• Minimum of 3–5 years of experience in the pharmaceutical industry, including at least 2 years in Regulatory Advertising and Promotion
• Expert knowledge of U.S. advertising and promotion regulations and FDA guidance documents
• Direct experience supporting promotional review of product communications and engaging with FDA (OPDP or APLB) on advertising and promotion matters
• Experience in rare diseases, hematology, and/or immunology is a plus
• Proficiency with Veeva Vault PromoMats
• General understanding of clinical study design and statistical analysis as it relates to promotional claims
• Familiarity with the drug development process and drug labeling
• Strong interpersonal and communication skills, with the ability to lead and influence without direct authority
• Ability to creatively analyze complex issues and develop practical, compliant solutions

What is the last date for applying to the job?

Which countries are accepted for this remote job?