Position:Associate Director, Regulatory Advertising and Promotions
Location:Boston, MA (Remote)
Length:6+ months
Job Description:
Our client is seeking an experienced and highly motivated Associate Director of Regulatory Advertising and Promotions to join their team. In this role, you will be responsible for providing strategic and tactical regulatory support and guidance for product and disease-state communications. This position requires working closely with cross-functional teams to ensure that promotional activities and communications comply with applicable regulatory requirements while meeting organizational objectives.
Essential Duties and Responsibilities (but not limited to):
- Provide regulatory expertise on product promotion, disease-state communications, and pipeline materials, ensuring compliance with applicable regulations.
- Serve as the regulatory reviewer for assigned products in various review committees (CRC, MRC) and represent Commercial Regulatory on cross-functional teams.
- Lead discussions in review committees, collaborating with stakeholders from Regulatory, Legal, Medical, and Commercial teams to reach consensus on promotional materials.
- Guide the integration of regulatory requirements into product and disease-state communications, including potential labeling claims and promotional materials for development products.
- Assess and interpret relevant regulatory guidelines, ensuring compliance in promotional materials and facilitating interactions with regulatory bodies.
- Ensure that changes in product labeling are accurately reflected in promotional materials, in line with internal procedures and regulatory standards.
- Contribute to the development and update of internal review processes, procedures, and guidelines.
- Monitor advertising and promotional regulations to support compliant marketing strategies and assess their impact on the business.
- Plan and conduct training sessions for internal stakeholders on regulatory compliance and promotional guidelines.
Qualifications:
- Bachelor's degree in a relevant/scientific discipline or a related field.
- 8+ years of experience or equivalent education and professional experience.
- Thorough understanding of applicable regulations, guidance, and industry standards related to advertising and promotional communications for prescription drugs, devices, and investigational treatments.
- In-depth knowledge of clinical study design and statistical analyses in the assessment of promotional claims.
- Strong interpersonal and communication skills with the ability to convey complex regulatory concepts and influence key stakeholders.
- Ability to innovate, analyze, and solve complex problems.
- Experience in the pharmaceutical industry, specifically in regulatory advertising and promotion, including interactions with regulatory agencies.
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
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- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
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Digital Prospectors
Mar 29, 2025