Job Information
Bausch Health Senior Regulatory Affairs Specialist in Bridgewater, New Jersey
Senior Regulatory Affairs Specialist
Job Location: Bridgewater, New Jersey, USA
Job Requisition ID: 14990
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. 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 Regulatory Affairs Specialist executes on the pharmaceutical regulatory strategies for assigned brand products. Supports the Regulatory Affairs senior team members for submission timelines and liaises with the country specific regulatory personnel for timely and accurate sharing of information to support compliance.
Key Responsibilites:
Provide support for the execution of the pharmaceutical regulatory strategy for assigned products
Support regulatory aspects of product development team for agency filing
Work with the Pharmaceutical Regulatory senior team members to make certain product documentation is developed in accordance with regulatory requirements; serve as designee as needed
Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned products
Liaise with country-specific regulatory affairs personnel for international submissions and registrations
Other job responsibilities as needed
This position is based in Bridgewater, NJ and follows a hybrid schedule, with in-office work Tuesday through Thursday and remote work on Monday and Friday
Occasional travel may be required
Qualifications:
4+ years relevant pharmaceutical industry and regulatory experience (or 2+ years Pharmaceutical Brand Experience with a Masters in Regulatory Affairs); 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
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
The range of starting base pay for this role is 98K-135K. 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, stock purchase plan, 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.
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We are an Equal Opportunity Employer. EOE Disability/Veteran. 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.