Bausch Health Manager, Regulatory Affairs - Labeling Requirements Specification in Saint Louis, Missouri
Manager, Regulatory Affairs - Labeling Requirements Specification (4079)
Career Opportunities: Manager, Regulatory Affairs - Labeling Requirements Specification (4079)
Requisition ID 4079 - Posted - Global Medical Devices - R&D - US - St. Louis (Tree Court) More (2) - City (7)
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Regulatory Affairs LRS Manager
The LRS Manager is responsible for the development and maintenance of Labeling Requirements Specification (LRS) templates and product specific content of LRS documents. Accountable to ensure product labels are accurate, compliant and maintained globally
Accountable for the creation and maintenance of labeling requirements specification (LRS) templates and product specific content of LRS for global products and ensure compliance with relevant FDA, MDR, ISO and other global regulations.
Accountable to ensure product labels are accurate, compliant and maintained globally.
Conduct standards assessments when new standards/regulations or changes to existing standards/regulations are published. Responsible to assess impact to current product labeling and execute change requests to facilitate labeling updates to meet current regulations.
Lead meetings and discussions with cross-functional teams (Regulatory Affairs (global/local), Medical Affairs, Engineering, Quality, Legal, Commercial, Site Labeling/Graphics Leads) to prepare, populate and drive alignment of labeling-specific content to meet requirements in the LRS.
Lead and track resolution process for any issues encountered during LRS development and approval.
Attend RA labeling requirements meetings and external standards meetings with Quality and cross-functional teams for labeling requirements
Other duties as assigned
Minimum of bachelor’s degree or equivalent.
A robust understanding of Medical Device product labeling.
Knowledge of international standards for labeling (e.g. ISO 15223-1)
Strong experience in leading cross-functional project teams.
Working Knowledge of MS office with proficiency in Excel, Word, and Power Point.
Working knowledge of change management systems/processes and documentation management.
Ability to read and comprehend technical documentation.
Strong communication skills (verbal & written) with ability to communicate with other scientific and engineering disciplines on a cross functional team.
5+ years relevant regulatory experience in a pharmaceutical or medical device industry
This position may be available in the following location(s): US - St. Louis (Tree Court), US - Bridgewater, NJ, US - Rochester, NY (GEHC)
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.
Bausch Health is an EEO/AA employer M/F/D/V.