The Director of Regulatory Affairs coordinates and oversees regulatory development and post-approval regulatory activities for prescription products of assigned portfolio. Active member of the product development team to provide regulatory guidance for pharmaceutical products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for pharmaceutical products. May perform due diligence efforts on new product opportunities.

Responsibilities:

• Responsible for establishing a product regulatory strategy for pharmaceutical products in the assigned therapeutic area
• Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development
• Ensure that development and execution of product regulatory timeline aligned to Bausch Health Companies (BHC) product development, with key regulatory milestone, and activities for agency filing
• Ensures regulatory deliverables are in place and delivered to time cost and quality pre- and post-approval dossier management. Ensures that data are identified, obtained, and effectively presented for successful filing, approval, registration, market launch, maintenance of business and regulatory compliance.
• Active member of 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
• Manage interactions with other BHC functions (e.g., Quality, Compliance) during Regulatory Authority inspections
• Provide regulatory guidance/input to internal product review boards
• Manage assigned personnel if applicable
• Requires three days/week onsite in the Bridgewater, NJ office
• Occasional travel may be required

Qualifications:

• Bachelor’s degree in science or health related field
• 10+ years relevant pharmaceutical industry and regulatory experience
• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle
• Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical 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 activities for pharmaceutical products 

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 177K – 210K 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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