Global Regulatory Affairs Lead

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 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 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 Global Regulatory Affairs Lead is responsible for driving the overall global regulatory and product strategy, including global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence, and change management. The role also oversees pharmaceutical, consumer, and medical device regulatory activities at the regional and local levels, partnering closely with commercial leaders to define strategy, execute registrations, provide regulatory intelligence, and ensure ongoing regulatory compliance across all markets.

Responsibilities:

• Interpret regulatory authority policies and guidance and apply them appropriately to product development and labeling activities. 
• Drive innovative and efficient approaches to regulatory submissions to enhance approval outcomes. 
• Critically review complex scientific and technical information to ensure arguments are clearly presented and conclusions are adequately supported by data. 
• Collaborate with key national opinion leaders and advisory boards; represent the company on relevant advocacy and industry groups. 
• Serve as the primary point of contact with assigned Health Authorities and effectively manage these regulatory relationships. 
• Monitor changes in the regulatory environment and proactively make strategic recommendations to minimize business risk. 
• Provide effective leadership, strategic direction, and ongoing support to the regulatory team. 
• Contribute input to the regulatory budgeting and planning process. 
• Set and execute regulatory strategies across the department.

Requirements:

• Bachelors degree preferred or equivalent required; advanced degree (Masters, PhD, PharmD) preferred 
• 10+ years in Regulatory Affairs or relevant experience in a regulated environment 
• Demonstrated business acumen, with the ability to understand and apply regulatory strategies in alignment with broader business objectives.
• Experience managing global regulatory portfolios, including direct involvement in regulatory strategy and lifecycle activities across regions such as the EU, AMEA, and Canada.
• Solid understanding of regulatory processes and supporting information systems, sufficient to execute and oversee global, regional, and local regulatory activities effectively.
• Ability to independently prioritize and manage multiple complex initiatives; coordinate resources across functions; and consistently meet aggressive timelines and deadlines.
• Ability to influence and collaborate effectively with internal and external stakeholders, including key opinion leaders (KOLs), while developing, mentoring, and leading teams of individual contributors and subject matter experts.
• Demonstrated ability to apply strong analytical reasoning and critical thinking to complex regulatory and business challenges, including appropriate risk assessment and decisive action in rapidly changing or unexpected situations.
• Proven ability to serve as a technical subject matter expert, providing accurate, credible expertise both internally and externally, with a high level of attention to detail and document quality.
• Demonstrated capability to coach and mentor individuals on subject matter expertise while contributing effectively within cross functional and team based environments.
• Excellent organizational, written, and verbal communication skills combined with strong interpersonal abilities to positively influence stakeholders and drive alignment.
• Demonstrated focus on operational excellence, performance metrics, continuous learning, and process improvement, including the ability to review documentation for accuracy, consistency, and compliance.

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.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $165,000.00 and $215,000.00.  The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Bausch + Lomb Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.