Associate Director, Regulatory Advertising and Promotion – Prescription Drug Products (Remote)
Job ID: 293446 | Location: Remote / Billerica, Massachusetts, United States | Job Type: Full-Time
Position Overview
EMD Serono is seeking an experienced Associate Director, Regulatory Advertising and Promotion to oversee the review, approval, and monitoring of prescription drug advertising and promotional materials. This role ensures compliance with U.S. regulatory requirements while supporting strategic promotional objectives for the company’s prescription drug products. The position is remote and offers a key opportunity to shape regulatory strategies in a leading pharmaceutical organization.
Note: This position does not offer sponsorship; candidates must be authorized to work in the U.S.
Key Responsibilities
Serve as the Regulatory Affairs representative on promotional review committees for prescription products, ensuring materials meet FDA regulations and company policies.
Implement regulatory strategies and provide solutions to ensure advertising and promotional materials comply with all applicable requirements.
Advise cross-functional teams on product claims, Important Safety Information (ISI), and Brief Summary documents.
Develop, revise, and enhance advertising and promotion-related processes and SOPs to maintain compliance and operational efficiency.
Monitor regulatory compliance trends and interpret new FDA guidance, enforcement letters, and Office of Prescription Drug Promotion (OPDP) updates, sharing key insights with internal stakeholders.
Collaborate with the Regulatory Affairs labeling team to assess the impact of proposed labeling changes on promotional materials.
Prepare regulatory communication packages, including responses to FDA action letters, and lead discussions with OPDP and APLB.
Coordinate and deliver company-wide regulatory training related to product promotion.
Provide strategic oversight, guidance, and mentorship to advertising and promotion review staff.
Scope of Role
Lead the strategic direction, review, and training of prescription drug advertising and promotional materials to ensure compliance with regulatory agency requirements and company policies.
Serve as a trusted regulatory partner across multiple business units, supporting compliance and promotional excellence.
Candidate Profile
Minimum Qualifications
Bachelor’s degree in Science or Health-related discipline (Advanced degree [MS, PharmD] preferred).
Minimum 4 years pharmaceutical industry experience, including 3 years in Regulatory Affairs focused on prescription product advertising and promotion review.
Strong understanding of FDA regulatory requirements for advertising and promotion.
Ability to assess documents accurately for compliance, consistency, and scientific integrity.
Excellent oral and written communication skills with strong interpersonal and leadership capabilities.
Ability to work effectively in a cross-functional team environment.
Preferred Qualifications
In-depth knowledge of regulations and guidance related to prescription drug promotion.
Working knowledge of Rx NDA, BLA, and labeling development and approval processes.
Demonstrated ability to lead cross-functional teams and influence stakeholders.
Detail-oriented, proactive, and able to manage multiple priorities efficiently.
Compensation & Benefits
Base Salary Range: USD 123,400 – 185,000 (actual compensation will be based on experience, education, location, and other job-related factors)
Eligible for performance-based incentives.
Benefits include health insurance, paid time off (PTO), retirement contributions, and additional perks.
Why Join EMD Serono?
At EMD Serono, we believe diverse perspectives and experiences drive innovation and excellence. Our inclusive culture empowers employees to grow, develop, and make meaningful contributions to healthcare. By joining our team, you will be part of a forward-thinking organization committed to improving lives and advancing scientific discovery.
Apply Today
Take the next step in your Regulatory Affairs career and contribute to ensuring compliant, impactful, and strategically aligned promotional materials for leading prescription drug products.
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