Regulatory Affairs Manager
Company: Bausch + Lomb
Posted on: May 15, 2022
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 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.
PURPOSE OF JOB Lead regulatory affairs project management for
international regulatory projects. Ensure R&D projects meet
global regulatory requirements for the global commercial marketing
strategy. Provide regulatory support to local / regional RA teams
(all global regions) to access B&L information platforms in
support of new Product Registrations, Renewals, variations, new
product launches, tenders, etc.
RESPONSIBILITIES Responsibilities may include but are not limited
--- Lead the Regulatory Affairs PMO (Project Management Office) for
International Regulatory Projects
--- Ensure R&D project plans align with the global commercial
strategy and global regulatory requirements.
--- Aligns regional submissions timelines with Commercial, Supply
Chain and Quality launch timelines based on status of design and
development projects, change implementation timelines and expected
approvals in registration reference countries, where required.
--- Responsible for the coordination of the development of the
Annual Project List for all regulatory activities.
--- Responsible for updating a global medical device project list
tracking all regulatory activity (registrations, renewals,
variations, notifications, etc)
--- Provide reporting to senior management and stakeholders for
KPIs (Key Performance Indicators)
--- Chair a set of regular project meetings with Regional RA Leads,
Commercial and R&D
--- Work cross functionally with the local / regional RA team, RA
Super Users, to direct regulatory requests to manufacturer -s team
experts, Supply Chain, Quality, R&D, SME (Subject Matter
Experts), and regional members to support regional needs for new
product registrations and product renewals for all cleared/approved
products across the whole company product portfolio.
--- Serve as an effective liaison between all stakeholders to
ensure that requirements and expectations are defined,
communicated, and understood.
--- Proactively manage and track program risks.
--- Project team leadership
--- Other job responsibilities as needed.
SCOPE OF POSITION
Regulatory Project Management for all Bausch & Lomb Incorporated
regions on -company marketed/cleared products.
Internal R&D, Regulatory, Manufacturing Sites, Commercial,
Quality, Supply Chain, Legal to support/ expand already approved
products throughout Bausch & Lomb Incorporated regions.
Regional functional groups (mainly Regulatory and Commercial)
External contract manufacturing organizations (CMO) and
--- Bachelor's degree in technical or scientific discipline such as
biology, chemistry, pharmacy, engineering, etc.
--- 8+ years project leadership experience within a regulated
industry (pharmaceuticals, medical devices, etc)
--- Must have excellent communication, organization, time
management, and writing skills.
--- Strong interpersonal skills required in areas of verbal and
written communications, service to internal customers, and
--- Strong questioning and problem-solving skills.
--- Must be self-motivated by working independently and having the
ability to take ownership of responsibilities.
We recognize your physical, financial, and emotional wellbeing is a
significant part of what allows you to be successful at work and at
home. Our generous benefits package includes:
Medical, Dental, and Vision Coverage
Flexible Spending Account (FSA)
401(k) Savings Plan
Employee Stock Purchase Plan
Employee Assistance Plan (EAP)
Parental Leave Program
Free Bausch + Lomb Contact Lenses
Group Legal Services
Education Assistance Program
Learn more at www.bausch.com
Keywords: Bausch + Lomb, Trenton , Regulatory Affairs Manager, Executive , Bridgewater, New Jersey
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