Bausch Health Jobs

Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence.

We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future.

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 Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Director is responsible for ensuring the pieces are incompliance with all applicable laws, regulations, and regulatory agency guidance.

Responsibilities:

• Manages or represents Regulatory Affairs on the promotional review committees for prescription products to review promotional materials to ensure compliance with regulatory requirements while meeting the Company's strategic promotional objectives.

• Implements regulatory strategies and solutions to assure that all advertising and promotional materials are incompliance with regulatory requirements and Company policies.

• Provides guidance and strategic support on proposed claims for products in development and helps develop Important Safety Information (ISI) and Brief Summary documents as appropriate.

• Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance.

• Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDAs Office of Prescription Drug promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business.

• Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.

• Develops communication packages for regulatory advice, response to FDA action letters, and leads the company in discussions with OPDP and APLB.

• Coordinates company-wide ongoing training on regulatory issues pertaining to product promotion. Other job responsibilities as needed.

Qualifications:

• Bachelors degree required. Science or health related discipline preferred. (Advanced degree [PhD, MD, MS, PharmD] highly preferred)

• Minimum 10 years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs prescription product advertising and promotion review experience. Supervisory experience. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.

• Knowledge of regulations related to prescription drug promotion

• Previous course and/or conference training in advertising and promotion

• Working knowledge of Rx NDA and labeling development and approval process

• Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency

• Strong interpersonal skills with the ability to influence, without authority, others in a positive and effective manner

This is a hybrid role - 3 days reporting to the Bridgewater office, 2 days remote.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

#LI-hybrid

This position may be available in the following location(s): [[location_obj]]

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Applicants should be aware of job offer scams perpetrated through the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/af4e247fc99befe729755d44229317a5dc5e5807) .

Bausch Health is an EEO/AA employer M/F/D/V.