Regulatory Affairs Manager

Company: Bausch + Lomb
Location: Bridgewater
Posted on: May 15, 2022

Job Description:

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.

OBJECTIVES/
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.

KEY ACTIVITIES/
RESPONSIBILITIES Responsibilities may include but are not limited to:

--- 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.

KEY RELATIONSHIPS

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 partners

QUALIFICATIONS/
TRAINING

--- 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 professionalism.
--- Strong questioning and problem-solving skills.
--- Must be self-motivated by working independently and having the ability to take ownership of responsibilities.

Comprehensive Benefits
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)
Life Insurance
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