What are the responsibilities and job description for the Associate Director, Regulatory Affairs (Advertising and Promotion) position at Bausch Health Companies Inc.?
Job Location: Bridgewater, New Jersey, USA
Job Requisition ID: 14896
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.
Key Responsibilities:
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.
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We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
Job Requisition ID: 14896
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.
Key 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
- 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
- This position is based in Bridgewater, NJ and follows a hybrid schedule, with in-office work Tuesday through Thursday and remote work on Monday and Friday
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.
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We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.