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Senior Director, Regulatory Affairs

2 months ago

Bridgewater, New Jersey, United States Bausch Health Full time


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.


OBJECTIVES/PURPOSE OF JOB: The Senior Director of Global Regulatory Operations is responsible for directing and managing the Regulatory Operations function consisting of operational strategy; development; implementation and maintenance of operational processes; regulatory publishing, including submissions tracking and archival activities; management of GRA SOPs and departmental CAPAs.

KEY ACTIVITIES/RESPONSIBILITIES:

  • Serve as a leadership team member for Global Regulatory Affairs
  • Lead and grow individuals on the Regulatory Operations team
  • Define and implement operational strategies, ensuring high quality submissions that meet business objectives
  • Ensure team is aware of current regulations and guidelines relevant to regulatory operations, standards, and submission requirements
  • Oversee the develop and implementation of operational processes, and procedures and development of document formatting standards and other best practices guidelines
  • Identify opportunities to streamline Regulatory Affairs processes to promote operational excellence
  • Provide direction and monitor compliance of mandated regulatory training to maintain compliance with company policies
  • Provide oversight and monitor the regulatory standards that defines who own, maintains, and drives implementation of SOPS and work instructions.
  • Active member of cross functional leadership teams to enhance regulatory technology
  • Develop and manage budget related to GRO activities

QUALIFICATIONS:

  • Expertise on the requirements for electronic and paper submission to major regulatory authorities
  • Strong knowledge of pharmaceutical industry systems, publishing tools, and technology that support an efficient and compliant regulatory organization
  • Full awareness pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations
  • Ability to maintain knowledge of current and emerging issues and trends in the regulatory environment.
  • Maintain training program curriculum that supports development and maintenance of skills for regulatory personnel.
  • Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business.
  • Ability to influence and partner within Regulatory Affairs and with Cross- Functional teams within the organization

EXPERIENCE:

  • 12 years relevant pharmaceutical industry experience
  • 8 years Regulatory Operations professional experience
  • Strong oral and written communication and interpersonal skills; problem-solving and organizational skills; and strong attention to detail and accuracy
  • Ability to work in a team environment and fast paced environment
  • Bachelor's degree in science or health related field

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-hybrid


This position may be available in the following location(s): US - Bridgewater, NJ

Bausch 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 to or call 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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To learn more please read Bausch Health's Job Offer Fraud Statement.