Bausch + Lomb Senior Regulatory Affairs Specialist in Wilmington, Massachusetts
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 Regulatory Affairs Senior Specialist will be responsible for supporting global regulatory information management (RIM) team.
Maintain regulatory product and registration data in RIM system for submissions, approvals, registration, and associated product details
Ensure data is available in a complete, accurate, and timely manner.
Monitor data quality in RIM systems
Maintain proficiency in RIM systems and maintain current knowledge of regulations, best practices, and guidelines related to RIM for Medical Device and Pharmaceutical Products.
Support and assist RA Leads for updating product details in RIM system
Support and assist RA Leads for updating product registration details in RIM system
User Security Management
Develop, manage, and distribute reports, dashboards, and templates in RIM systems to meet user needs
Support system validation activities, including URS and test script creation.
Support CAPAs, Nonconformance (NC) and change control processes.
Other job responsibilities as needed
Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to the Health Authorities, as well as any post marketing labeling changes.
Review new labeling for accuracy and for other regulatory requirements
Liaise with Regulatory Affairs members and other cross-functional teams
(e.g., supply chain, legal, medical, pharmacovigilance) to ensure theaccuracy of all information included on the label or in the labeling.
Other job responsibilities as needed.
Working knowledge and understanding of drug development process and key data points for drug product details and drug product registration in various regions/countries including United States, Canada and EU region.
Working knowledge and understanding of RIM Systems.
Knowledge of good documentation practices and requirements for managing regulated records.
Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.
Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project).
Strong Quality Compliance background, preferably related to RegulatoryAffairs and Expertise of Quality Regulatory Compliance system.
Strong capability to contribute to a team environment.
Capacity to react quickly and decisively in unexpected situations.
5+ years of Pharmaceutical (or similar area) Regulatory Operations experience with RIM systems and software.
Bachelor’s degree required.
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.
To learn more please readBausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .
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.
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