Director, Regulatory Affairs

at Bausch + Lomb in Pocatello, Idaho, United States

Bausch + Lomb ( NYSE / TSX : BLCO ) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the worldfrom 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 iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

The Director, Regulatory Affairs leads global regulatory strategy, reporting, compliance, labeling, and regulatory intelligence to support product development, approval, and market expansion. This role provides regulatory leadership for ophthalmology drug and combination product programs from early development through registration and global launch, using a U.S.-led approach aligned with key exU.S. regions.The Director partners crossfunctionally with Clinical, Nonclinical, CMC , Quality, Safety, and Regulatory Operations to develop global regulatory strategies, lead health authority interactions, ensure highquality submissions, and manage regulatory risk across the product lifecycle. Responsibilities include preparation for and leadership of health authority meetings (e.g., preIND, endofphase, preNDA/ BLA ).The Director, Regulatory Affairs typically includes people and/or matrix leadership of regulatory teams and external vendors.

Responsibilities:

+ Define and execute global regulatory strategies for ophthalmology drug and combination product programs, aligned with development, CMC , and commercial objectives.

+ Provide guidance and direction regarding regulatory strategy to department.

+ Interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities.

+ Drive innovative strategies to enable successful regulatory submissions and improve the probability of approval.