Location: United States (Remote)
Job Type: Full-Time
Company: EMD Serono
Job ID: 293173
EMD Serono is seeking an experienced Associate Director, Regulatory Advertising & Promotion to lead the review and regulatory oversight of advertising and promotional materials for prescription drug products, with a dedicated focus on oncology. This position ensures that all promotional content complies with FDA regulations, industry standards, and internal policies while supporting the organization’s strategic commercial objectives.
This remote-based role is ideal for professionals with strong regulatory expertise in prescription drug promotion, cross-functional leadership skills, and experience navigating US regulatory frameworks.
Note: This role does not provide sponsorship. Applicants must be legally authorized to work in the United States.
Lead Regulatory Affairs representation on promotional review committees, ensuring all advertising and promotional materials comply with FDA requirements and company policies.
Implement regulatory strategies that guide the development, approval, and maintenance of US promotional materials for prescription products.
Provide regulatory guidance on messaging, product claims, and proposed promotional strategies for marketed and pipeline products.
Develop and review Important Safety Information (ISI), Brief Summaries, and related promotional documents.
Monitor regulatory trends, enforcement actions, and new FDA guidance from OPDP and APLB to ensure company-wide compliance.
Communicate regulatory updates and emerging trends to review committees, cross-functional teams, and leadership.
Collaborate with the labeling team to assess the promotional impact of package insert updates.
Prepare regulatory submission packages, respond to FDA queries, and lead discussions with OPDP and APLB.
Deliver company-wide training on promotional regulations and support continuous improvement of internal processes, SOPs, and compliance frameworks.
Provide regulatory insights that support product launches, particularly within oncology.
This leadership position manages the strategic direction, training, and regulatory review of advertising and promotional materials for prescription drug products, ensuring alignment with organizational standards and industry regulations.
Bachelor’s degree in a scientific or health-related discipline
(Advanced degrees such as MS or PharmD are preferred)
4+ years of pharmaceutical industry experience
Minimum 3 years of Regulatory Affairs experience focused on prescription drug advertising and promotion
Experience in oncology product promotion and product launches is preferred
Strong knowledge of FDA regulations governing prescription drug advertising and promotion
Working understanding of NDA, BLA, and labeling development processes
High attention to detail and the ability to assess promotional materials for accuracy and consistency
Excellent written and verbal communication skills
Strong interpersonal skills with the ability to influence and collaborate across cross-functional teams
Broad knowledge of regulatory affairs in the pharmaceutical industry
Base Salary Range: USD $123,400 – $185,000
(Final compensation based on experience, skills, and location)
Eligible for performance-based bonuses
Comprehensive benefits package including:
Health insurance
Paid time off (PTO)
Retirement contributions
Additional employee programs and perks
Remote position (United States)
Opportunity to collaborate with global teams across multiple regions
EMD Serono fosters a diverse, inclusive, and innovation-driven work culture. As part of the global Healthcare business, you will contribute to advancing patient care in therapeutic areas such as oncology, neurology, and fertility. The organization is committed to professional development, scientific excellence, and creating opportunities that empower individuals worldwide.
If you are a regulatory professional with expertise in advertising and promotion for prescription drug products, particularly within oncology, we encourage you to apply and contribute to advancing innovative healthcare solutions.
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