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.

Responsibilities:

• 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
• Position is primarily remote. Candidates must be available to work onsite at our Bridgewater, NJ office one Tuesday–Thursday per month
• 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

The range of starting base pay for this role is 165K - 226K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

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, 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.