Senior Principal Regulatory Affairs Specialist

Job Opportunity At Bausch + Lomb

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world from the moment of birth through every phase of life. Our mission is simple, yet powerful : helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives.

Our objective is to lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical / non-clinical, labeling, adpromo areas. We will serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.

Responsibilities include formulating, leading, and driving integrated regulatory strategies across CMC and clinical / non-clinical, labeling, adpromo domains. Providing technical expertise and regulatory direction to project teams throughout the product lifecycle. Proactively communicating strategy, risks, and critical issues to stakeholders and senior leadership. Influencing internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives. Serving as primary regulatory point of contact with Health Authorities and managing ongoing relationships. Participating in assigned due diligence activities for business development and acquisitions. Leading all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. Planning, authoring, reviewing, and coordinating high-quality submission components for IND, NDA, ANDAs and amendments / supplements. Serving as RA representative on facility / site Local Change Management Boards. Ensuring operational excellence, compliance, and timely execution of deliverables. Driving regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements. Providing guidance on risk assessment, clinical trial design implications, and regulatory pathways. Supporting interactions with Health Authorities for development programs. Ensuring high-quality submissions by proofreading and checking documents for accuracy and consistency. Contributing to continuous learning, process improvement, and knowledge-sharing initiatives. Mentoring and coaching team members in regulatory strategy and submission excellence. Monitoring and reporting on performance metrics to drive operational effectiveness. Participating in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.

Qualifications include a bachelor degree or equivalent, master degree preferred. Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment. Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate. Strong business acumen and ability to see the business drivers outside of Regulatory Affairs. Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval. Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data. 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. Excellent communication skills; both oral and written. Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business. Capacity to react quickly and decisively in unexpected situations. Ability to influence external regulatory stakeholders and shape the external regulatory environment. Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure. The ability to work with key national opinion leaders, and advisory boards.

We offer competitive salary & excellent benefits including medical, dental, eye health, disability and life insurance begins on your hire date. 401K Plan with company match and ongoing company contribution. Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time. Employee Stock Purchase Plan with company match. Employee Incentive Bonus. Tuition Reimbursement (select degrees). Ongoing performance feedback and annual compensation review.