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 iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. 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.

Objectives : Responsible for the overall product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management for consumer products (Rx / OTC, OTC Monograph, Nutritional, and Cosmetics).

Responsibilities :

• Interpret Regulatory Authority policies, regulations and guidances and correctly apply them, as appropriate
• Provide technical expertise internally and / or externally as subject matter expert
• Participate in external industry forums (such as trade associations, committees and regulatory boards) as required and influence externally
• Represent BNL in external committees and boards as required
• Coach and mentor individuals on subject matter expertise
• Provide guidance and direction regarding regulatory strategy to project teams
• Participate in assigned due diligence activities for business development and acquisitions
• Utilize multiple regulatory databases to ensure the stringent accuracy of information for creation of cosmetics, OTC Drug Facts and nutritional / natural health products in the US and / or Canada
• Formulate, lead, and drive integrated regulatory strategies across CMC and clinical / non-clinical, labeling, adpromo domains
• Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC products and dietary supplements
• Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDA amendments / supplements
• Review raw materials and formulations, provide advice to product development teams and give guidance on potential regulatory compliance issues
• Point of contact with Health Authorities and ability to manage the relationship with Health Authorities

Qualifications :

We offer competitive salary & excellent benefits including :

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.