Associate Director, Regulatory Affairs (Advertising and Promotion)

Bausch Health • Bridgewater, NJ

4d • Hybrid

About The Position

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. The Associate Director Regulatory Advertising & Promotion reviews, approves, and submits Bausch Health Companies, Inc (BHC) prescription drug product advertising, and promotional labeling pieces in compliance with FDA requirements and company policies.

Requirements

• Bachelor’s degree required. Science or health related discipline preferred. (Advanced degree [PhD, MD, MS, PharmD] preferred)
• Minimum of 6 years of relevant pharmaceutical industry experience with 4+ years of relevant prescription product
• Knowledge of regulations related to US prescription drug promotion
• Knowledge of promotional review process (PRC)
• Ability to provide expertise on regulatory advertising and promotion to regulatory advertising & promotion review team
• Ability to interpret FDA regulations & guidance documents and company policies related to prescription drug promotion
• Ability to influence and partner with cross-functional teams in a pharmaceutical organization
• Ability to critically review detailed scientific information and assess whether such information is appropriate for prescription drug promotion
• Knowledge of regulatory affairs discipline throughout the prescription drug lifecycle, including Development, Promotion and Advertising, & Labeling
• Ability to assess US promotional risks, as needed

Responsibilities

• Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products in consultation with Head of Regulatory Ad/Promo.
• Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements
• Develops Important Safety Information and Brief Summaries in consultation with Head of Regulatory Ad/Promo for assigned products
• Ensure timely implementation of safety updates into promotional materials driven by changes to the full Prescribing information for assigned products
• Submits on Form 2253 prescription drug product advertising and promotional labeling pieces in compliance with FDA requirements for assigned products

Benefits

• Benefits package includes comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, 3-weeks paid time off plus paid sick time, stock purchase plan, tuition reimbursement, parental leave, short- and long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), employee referral bonuses and employee discounts.

What This Job Offers

• Job Type: Full-time
• Career Level: Director