Associate Director, Regulatory Affairs

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 Associate Director, Regulatory Affairs handles regulatory development and post-approval/regulatory compliance for assigned products. Participates on the product development/life-cycle management team to provide regulatory guidance for assigned pharmaceutical products. Primary focus on approved products (NDA; ANDA; BLA; OTC; Devices; Cosmetic; Nutritional). Manages relevant regulatory strategy components and interactions with Regulatory Authorities for these products. May perform due diligence efforts on new product opportunities.

Key Responsibilties:

• Responsible for developing a product regulatory strategy for pharmaceutical products
• Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
• Develop a product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestone, and activities for agency filing
• Coordinate with the Labeling Lead for the development/maintenance of product labels
• Ensure labeling content and product documentation is developed in accordance with regulatory requirements
• Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
• Coordinate with Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities
• Act as a regulatory contact with Regulatory Authorities for assigned pharmaceutical products.
• Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and registrations
• Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections
• Provide regulatory guidance/input within business development and due diligence opportunities.
• Preparation of yearly plan activities and regulatory budget proposal, when necessary, based on business plans.
• Other activities and tasks within RA area as assigned by Supervisor.
• Manage assigned personnel if applicable
• Requires 3 days onsite per week in our Bridgewater, NJ office.
• Occasional travel may be required
  
  

Qualifications:

• 6 - 8 years relevant pharmaceutical industry and regulatory experience; Pharmaceutical Rx experience highly preferred
• Bachelor’s degree in science or health related field
• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product/dossier management lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations
• Knowledge of domestic and international laws, regulations, and guidance that affect Brand products
• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
• Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory
• Regulatory Affairs Certification by RAPS a plus
  
  

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.

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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 tohumanresources@bauschhealth.comor 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 readBausch 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.