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.
This position is a hybrid role based in our Citywest, Dublin office.
ResponsibilitiesLead labeling artwork development and revision projects. Coordinate with subject matter experts to ensure all labels are compliant with regulations, guidance, internal quality process, and label control/issuance. Responsible for final product label review and approval within the labeling process. Follow, support and improve processes to ensure label accuracy and timeliness of deliverables. Provide technical expertise, leadership and project coordination. Responsible for post approval lifecycle management of labeling.
DutiesExcellent communication / interpersonal and writing skills.Self-motivated and capable of working with supervision and guidance.Knowledge in technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project).Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies.Command of English language (verbal and written).Ability to work and contribute to a team environment.Ability to understand scientific and regulatory requirements.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.RequirementsMinimum Associate degree, Bachelor degree preferred or equivalent.1 plus year of Regulatory Affairs experience or relevant experience in a regulated environment.Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
#J-18808-Ljbffr