Associate Director, Regulatory Advertising & Promotion – Oncology Prescription Drug Products
Job ID: 293173 | Location: Remote, Billerica, Massachusetts, United States | Job Type: Full-Time
Position Overview
EMD Serono is seeking a skilled Associate Director, Regulatory Advertising & Promotion – Oncology to lead and oversee the review, approval, and monitoring of prescription drug advertising and promotional materials. This role ensures all promotional content complies with applicable US laws, FDA regulations, and internal company standards, supporting strategic oncology product launches and communications.
Note: This position does not offer sponsorship; candidates must be authorized to work in the U.S.
Key Responsibilities
Represent Regulatory Affairs on promotional review committees to ensure oncology promotional materials comply with US regulatory requirements while supporting company objectives.
Implement regulatory strategies to ensure advertising and promotional materials meet FDA guidelines, company policies, and industry best practices.
Provide guidance on proposed claims for oncology products in development, including creation of Important Safety Information (ISI) and Brief Summary documents.
Develop, assess, and enhance SOPs and processes related to advertising and promotion to improve efficiency and compliance.
Monitor industry trends, interpret new regulations, guidance documents, and enforcement letters from FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB).
Collaborate with Regulatory Affairs labeling teams to assess the impact of package insert changes on promotional content.
Prepare regulatory communication packages, respond to FDA action letters, and lead interactions with OPDP/APLB.
Coordinate company-wide training on regulatory issues related to advertising and promotion.
Manage strategic direction and provide guidance to cross-functional teams regarding oncology promotional content.
Candidate Profile
Minimum Qualifications
Bachelor’s degree in science or health-related discipline (Advanced degree [MS, PharmD] preferred).
4+ years of pharmaceutical industry experience, including 3+ years in Regulatory Affairs advertising and promotion review, preferably with oncology products.
Knowledge of FDA regulations related to prescription drug promotion.
Strong detail orientation with the ability to evaluate documents for accuracy and consistency.
Excellent written and verbal communication skills.
Ability to collaborate effectively across cross-functional teams.
Preferred Qualifications
Experience with oncology product promotion and launches.
Working knowledge of Rx NDA, BLA, and labeling development/approval processes.
Strong interpersonal skills with the ability to lead, influence, and mentor colleagues.
Broad understanding of Regulatory Affairs for prescription drugs within the pharmaceutical industry.
Location
Remote – candidates must reside in the United States.
Compensation & Benefits
Base Salary Range: USD 123,400 – 185,000 (actual compensation will depend on experience, education, location, and other factors).
Eligible for performance-based bonuses.
Comprehensive benefits including health insurance, paid time off (PTO), retirement contributions, and other perks.
Why Join EMD Serono?
At EMD Serono, we embrace diverse backgrounds, perspectives, and experiences to drive innovation and excellence. Join a collaborative and inclusive culture where you can advance your career while ensuring the safe, compliant, and effective promotion of oncology products.
Apply Today
Take the next step in your Regulatory Affairs career and become a strategic leader in oncology promotional review, shaping impactful communications that support patients, healthcare providers, and the company’s growth.
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