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Regulatory Affairs Specialist I

3 months ago

Brockton, Massachusetts, United States Bausch + Lomb Full time

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.

Position Objectives/Responsibilities

The Proofreader supports RA with proofreading activities for artwork development, revision, and lifecycle management projects.

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.

Proofread labeling content against regulatory and company standards for consistency, compliance, copy editing, and spelling checks.


Proofread/review labeling and packaging component artwork annotations/redlines and final artwork in Digital Workflow system for approval (manual read and/or utilizing text comparison software TVT).

Update labeling source documents (Word documents) for current approved Rx Prescribing information (Package Insert/Patient Information/IFUs/Med Guides) as applicable.

Ensure labeling is compliant per procedures and checklists and all requested changes have been made.

Utilize proofreading tools to complete text review.

Other job responsibilities as needed.

Requirements:

Minimum Associate degree, Bachelor degree preferred or equivalent

0-1 year of Regulatory Affairs experience or relevant experience in a regulated environment

Excellent communication / interpersonal skills and writing

Self-motivated and capable of working with supervision and guidance Knowledge in basic 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

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

Ability to simultaneously manage multiple projects and tasks

Proficient in software tools for the development and revision of Structured Product Labeling

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(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.

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.