Associate Director, Regulatory Affairs

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. 

Objectives/Responsibilities

• Provide Regulatory support and guidance in the development, revision, review, and approval of labeling artwork for Health Authorities submissions, as well as any post marketing labeling changes.
• Responsible for post approval lifecycle management of labeling.
• Coordinate with Regulatory Affairs members and other cross-functional teams to ensure the accuracy of all information included on the label or in the labeling and all labels are compliant with regulations, guidance, internal quality process, and label control/issuance.
• Follow, support, and improve processes to ensure label accuracy and timeliness of deliverables.
• Provide technical expertise, leadership, and project coordination. Guide and mentor specialist level team members.
• Develop and maintain tools/lists that support the coordination with other functions (eg: Quality, manufacturing) to make certain only agency approved labels are produced for appropriate products.
• Train new hires.
• Other job responsibilities as needed.

Core Skills/Knowledge

• Strong working knowledge of regulatory guidelines, development, manufacturing, and commercialization of products.
• Strong organizational skills and excellent in managing multiple priorities.
• Excellent communication skills (oral and written).
• Computer Literacy - Microsoft Package including Word, Excel, and Outlook, Adobe Acrobat.
• Entrepreneurship and focus on customer needs; good business acumen and sense of urgency; agility and flexibility.
• Advanced Project Management / leadership experience.
• Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase 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.
• Knowledge of current and emerging issues and trends.
• Communicate with regulatory authorities on the companies' behalf.
• Strong capability to lead a larger team, teach and mentor/develop team members.
• Ability to prioritize assignment of projects, coordinate resources simultaneously and work with tight deadlines.

Specific Skills/Knowledge

• Knowledge of pharmaceutical, consumer or medical device industry product labeling processes for review and obtaining regulatory approvals.
• Knowledge of pharmaceutical, consumer or medical device industry Regulatory Affairs discipline throughout the product lifecycle including Development, Commercialization and Operations.
• Strong technology skills, especially with Microsoft Office and web-based applications.
• Ability to read and comprehend technical information such as regulations and standards.
• Ability to critically and efficiently review detailed information to support labeling creation and revision.
• Simultaneously manage multiple projects and tasks.
• Ensure labeling is compliant per procedures and checklists and all requested changes have been made.
• Utilize proofreading tools to complete text review. Proficient in software tools for the development and revision of Structured Product Labeling,

Minimum Qualifications

Bachelor's degree preferred.
Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment.

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.

This position may be available in the following location: Bridgewater NJ

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.
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.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

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.