Job description

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 worldfrom 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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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 Sr. Specialist, Labeling is reponsible for leading labeling artwork projects for the development of new and changes to existing product labeling components for Pharmaceutical and/or Consumer products.

Key Activities/Responsibilities:
Manages labeling artwork projects for the development of new and changes to existing product labeling components (including package inserts, medication guides, patient/pharmacist information inserts, instructions for use, container labels, and cartons, etc.).

Provides labeling component artwork files to support initial submissions and post-approval labeling changes.

Review new labeling for accuracy and for other regulatory requirements.

Evaluates content of labeling on all labeling component artwork to ensure compliance with regulatory requirements and company guidelines (branding, trademarks, etc.).

Collaborates and facilitates review and approval processes with appropriate cross-functional teams (such as Regulatory Affairs Product Lead, CMC, Graphics, Legal, Quality, Supply Chain, Marketing, Engineering) and external parties to develop new or update existing labeling component artwork.

Monitors, evaluates and recommends improvements to labeling process, systems, tools and/or procedures.

Train new hires.

Other job responsibilities as needed.

Qualifications/Training:
Technical Competencies

Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations.

Knowledge of FDA regulations relating to submissions and regulatory approval of drug products.

Knowledge of pharmaceutical industry product labeling processes for review and obtaining regulatory approvals.

Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.

Ability to critically and efficiently review detailed information to support a labeling revision.

Strong technical knowledge of drug listing and SPL.

Professional Competencies

Demonstrated ability in analytical reasoning and critical thinking skills.

Ability to contribute and lead in a team environment.

Ability to understand and apply business drivers outside of Regulatory Affairs.

Strong communication skills, both oral and written.

Strong interpersonal skills with the ability to influence others in a positive and effective manner.

Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies; able to do so quickly without sacrificing attention to detail.

Experience:
Possess 8+ years relevant pharmaceutical industry and regulatory experience, 4+ years' experience within pharmaceutical labeling, and a Bachelor's degree or higher. Applied knowledge of FDA labeling requirements, familiarity with XML concepts including structured product labels (SPL's) preferred.

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This position may be available in the following location(s): [[location_obj]]

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.

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

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