Associate Director, Regulatory Affairs Advertising and Promotion

Overview

• Salary up to $
• Opportunity for career advancement and growth within a pioneering biotechnology company
• Comprehensive benefits package including medical, dental, vision, and life insurance
• Generous paid time off policy including a minimum of 15 days of vacation and additional holidays
• Supportive work environment that values inclusion and diversity
• Participation in employee resource groups and tuition reimbursement up to $10,000 per year

• Provide regulatory strategic input and risk assessment for promotional and medical communications
• Serve as the primary contact with the Office of Prescription Drug Promotion (OPDP) for designated products
• Ensure compliance of promotional materials with FDA regulations and submission requirements
• Develop strong working relationships with cross-functional teams including Commercial, Medical, and Legal
• Assist in monitoring the evolving regulatory landscape and communicate updates to stakeholders

• BS degree required; advanced degree preferred
• Minimum of 5 years of experience in regulatory promotional review
• Detail-oriented with strong organizational skills
• Ability to analyze risk and communicate effectively across teams
• Exceptional verbal, written, and presentation skills

• Experience in a fast-paced and compliant environment
• Proven negotiation and interpersonal skills to influence and build collaboration
• Familiarity with complex disease information and product efficacy/safety data

#Biotechnology #Regulatory Affairs #Career Opportunity #Competitive Pay #Diversity And Inclusion

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.

We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.