Director of Regulatory Affairs. Job in Billings LilyLifestyle Jobs

Bausch + Lomb is a leading global eye health company dedicated to improving the vision of millions around the world from birth through every stage of life. Our mission is powerful: helping you see better, to live better. With a robust portfolio of over 400 products, we cater to our customers’ wide-ranging eye health needs seamlessly throughout their lives. Our iconic brand is built on deep trust and loyalty, cultivated over our 170‑year history. We are positioned to continue leading the advances in eye health, backed by a global team of about 13,000 employees spanning approximately 100 countries, reaching billions of potential customers. The Director of Regulatory Affairs plays a vital role in shaping global regulatory strategies, ensuring compliance, and leading regulatory intelligence efforts to support innovative product development, approval, and market expansion. This role will involve leading regulatory initiatives for ophthalmology drugs and combination products, from early development through to global launch. You'll collaborate with cross‑functional teams including Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations to develop effective regulatory strategies, manage health authority interactions, and ensure high‑quality submissions throughout the product lifecycle. Key Responsibilities Define and execute global regulatory strategies for ophthalmology drug and combination product programs, ensuring alignment with development, CMC, and commercial goals. Provide guidance on regulatory strategies to the department. Interpret and apply Regulatory Authority policies and guidance in product development and labeling activities. Develop innovative strategies that enhance the likelihood of successful regulatory submissions. Serve as the primary contact with Health Authorities and effectively manage these relationships. Mentor and develop a team of regulatory subject matter experts and individual contributors. Contribute to the regulatory budget process. Qualifications Bachelor’s degree required; advanced degrees (Masters, PhD, PharmD) preferred. 10‑15+ years of experience in Regulatory Affairs or a similar regulated environment. Experience in global portfolio management and a strong understanding of registration requirements in non‑U.S. regions. RAPS certification is desirable. Specific Skills In‑depth understanding of regulatory authority policies and processes, with the ability to apply these in various submissions. Strong analytical skills to evaluate data and provide regulatory expertise both internally and externally. A strategic mindset with the acumen to make risk‑based recommendations and drive approvals while minimizing business impact. Proven leadership abilities, including mentoring, influencing teams, and providing strategic direction beyond direct reports. Excellent communication and organization skills, with a keen attention to detail. Demonstrated ability to manage multiple priorities and work independently in a fast‑paced environment. Strong interpersonal skills to engage diverse stakeholders, including KOLs and advocacy groups. Commitment to teamwork, continuous improvement, and performance excellence. We offer a competitive salary and comprehensive benefits, including: Medical, Dental, Eye Health, Disability, and Life Insurance starting on the hire date. 401K Plan with company match and ongoing contributions. Paid time off (3 weeks, prorated upon hire), floating holidays, and sick leave. Employee Stock Purchase Plan with company match. Employee Incentive Bonus. Tuition Reimbursement for select degrees. Annual performance feedback and compensation reviews. We are an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. The starting pay for this role ranges from $165,000 to $220,000, with actual salary depending on various factors. Applicants must be authorized to work without sponsorship in the U.S. #J-18808-Ljbffr