Senior Regulatory Affairs Specialist

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 Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for assigned brand products. Supports for Brand submission timelines and liaises with the country specific regulatory personnel for timely and accurate sharing of information to support compliance.

Key Responsibilities:

• Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products
• Support regulatory aspects of product development team for agency filing
• Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance with regulatory requirements; serves as designee as needed
• Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned brand products
• Liaise with country-specific regulatory affairs personnel for international submissions and registrations
• Demonstrated ability in analytical reasoning and critical thinking skills
• Strong capability to contribute to a team environment
• Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
• Excellent communication skills; both oral and written
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Capacity to react quickly and decisively in unexpected situations
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Focused ability to influence operational excellence and performance metrics
• Risk adverse where needed with the ability to identify potential solutions to complex problems
• Requires 3 days/week onsite in Bridgewater, NJ office.
• Occasional travel may be required
• Other job responsibilities as needed

Qualifications:

• Bachelors degree required, in life sciences or health related disciplines preferred. Master's degree preferred.
• 2+ years of relevant pharmaceutical industry and regulatory experience; brand experience preferred
• Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization and Operations
• Knowledge of domestic and international regulations laws, regulations, and guidance
• Knowledge of clinical development, including responsibilities for successful management of development milestones and market authorization
• Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
• Ability to understand scientific information and assess whether technical arguments are articulated clearly
• Ability to assess project risks and where appropriate, escalate accordingly

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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We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, disability, military and/or veteran status, or any other Federal or State legally protected classes.

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 to humanresources@bauschhealth.com or 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.

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