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.Job Scope: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.Key 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
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-hybridBausch 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 [email protected] 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.