Associate Director, Global Regulatory Affairs Advertising and Promotion

Job Title: Associate Director, Global Regulatory Affairs Advertising and Promotion

Location: Cambridge, MA   Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

This individual will be responsible for providing regulatory review and approval of US promotional and other product and disease-related materials for assigned products. As the product expert, this individual helps to develop and implement regulatory strategies related to promotional and advertising campaigns for marketed products and development projects. Provides input into labeling strategies for investigational and marketed products impacting potential US product promotion. Liaises with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB).

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

• Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and portfolio team review committees (RC), providing regulatory input into the review and approval of US advertising, promotion, disease-state, market access, and press materials. Submits materials on form FDA 2253 when applicable.

• Provides US RA AdPromo strategic guidance and subject matter expertise for responsible investigational and marketed products, to meet both short- and long-term business objectives while mitigating risk. Consults with senior management and provides input to the Global organization as needed.

• Contributes US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.

• Primary Liaison with OPDP/APLB and effectively manages relationships with FDA contacts. Establishes and maintains strong collaborative relationships with Regulatory and other R&D colleagues, as well as other stakeholders (e.g., Legal, Medical, Marketing, Communications and Compliance).

• Participates in the development, monitoring and updating of standards and processes related to drug, device, and biologics US AdPromo regulations and guidances.

• Attends industry and medical congress meetings as appropriate for professional and personal growth within the US RA AdPromo discipline

About You

• Earned Bachelor's degree in a relevant life sciences degree
• Successful track record with a minimum of 1 year (3+ years preferred) of regulatory experience, preferably within the pharmaceutical/medical device/biotech industry
• Knowledge and understanding of complex medical and scientific subject matter is extremely helpful
• Significant understanding of the U.S. pharmaceutical marketplace, especially the rules and regulations related to the promotion of prescription drugs in the US is highly preferred
• Working knowledge of major digital and social media communications platforms is required
• Understands issues, challenges, and opportunities by comparing data from different sources to draw conclusions and choose a course of action or develop the appropriate solution
• Develops collaborative relationships to facilitate the accomplishment of work goals
• Develops and proposes innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
• Shows ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans
• Ability and desire to work well within cross-functional teams
• Demonstrates exceptional oral and written communication skills with a history of success
• Ability to balance projects with day-to-day duties, ensuring participation from other members of the department as needed
• Establishes priorities and timelines to effectively manage workload, including working with shifting priorities as needed

Why Choose Us?

• Bring the miracles of science to life alongsid