Manager, Regulatory Affairs (LRS
Company: Bausch Health
Location: Saint Louis
Posted on: April 9, 2021
Career Opportunities: Manager, Regulatory Affairs (LRS) (4079)
Requisition ID--4079-----Posted--04/01/2021-----Global Medical
Devices-----R&D-----US - St. Louis (Tree Court) 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
- 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
- Other duties as assigned Qualifications:
- Minimum of bachelor's degree or equivalent.
- A robust understanding of Medical Device product labeling.
- Knowledge of international standards for labeling (e.g. ISO
- Strong experience in leading cross-functional project
- Working Knowledge of MS office with proficiency in Excel, Word,
and Power Point.
- Working knowledge of change management systems/processes and
- 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)
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or veteran
Job Applicants should be aware of job offer scams perpetrated
through the use of the Internet and social media platforms.
To learn more please read--Bausch Health's Job Offer Fraud
Keywords: Bausch Health, St. Louis , Manager, Regulatory Affairs (LRS, Executive , Saint Louis, Missouri
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