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:

• Minimum 6 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

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 165K - 180K annually.

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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