Senior Director, Regulatory Affairs

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 Opera ti ons is responsible for direc ti ng and managing the Regulatory Opera ti ons func ti on consis ti ng of opera ti onal strategy;
• development; implementa ti on and maintenance of opera ti onal processes; regulatory publishing, including submissions tracking and archival ac ti vi ti es;

management of GRA SOPs and departmental CAPAs.

KEY ACTIVITIES / RESPONSIBILITIES :

• Serve as a leadership team member for Global Regulatory A ff airs
• Lead and grow individuals on the Regulatory Opera ti ons team
• De fi ne and implement opera ti onal strategies, ensuring high quality submissions that meet business objec ti ves
• Ensure team is aware of current regula ti ons and guidelines relevant to regulatory opera ti ons, standards, and submission requirements
• Oversee the develop and implementa ti on of opera ti onal processes, and procedures and development of document forma tti ng standards and other best prac ti ces guidelines
• Iden ti fy opportuni ti es to streamline Regulatory A ff airs processes to promote opera ti onal excellence
• Provide direc ti on and monitor compliance of mandated regulatory training to maintain compliance with company policies
• Provide oversight and monitor the regulatory standards that de fi nes who own, maintains, and drives implementa ti on of SOPS and work instruc ti ons.
• Ac ti ve member of cross func ti onal leadership teams to enhance regulatory technology
• Develop and manage budget related to GRO ac ti vi ti es

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.

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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 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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