Senior Manager Regulatory Advertising and Promotion - Remote

Overview

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).

In Short

• 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 to ensure that product and disease-state communications meet regulatory requirements.
• Monitor the external environment for evolving regulatory requirements related to advertising and promotion.
• 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.
• Ensure changes in product labeling are implemented into promotional materials.
• Represent Regulatory Advertising and Promotion on cross-functional project teams.
• Collaborate to optimize the material review process.

Requirements

• 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.
• Expert knowledge of U.S. advertising and promotion regulations.
• Direct experience supporting promotional review of product communications.
• Experience in rare diseases, hematology, and/or immunology is a plus.
• Proficiency with Veeva Vault PromoMats.
• Strong interpersonal and communication skills.
• Ability to creatively analyze complex issues and develop practical solutions.

Benefits

• Competitive compensation for your work.
• Generous time off policy.
• Summer Fridays.
• Opportunity to attend popular conferences.
• Emphasis on work/life balance.
• Collaborative and team-oriented environment.
• Making a positive impact on ultra-rare disease patients.