Senior Regulatory Affairs Specialist

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 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 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.

Position Objectives and Responsibilities

• Global – Responsible for supporting the overall product strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management
• Regional and/or Local - Responsible for pharmaceutical, consumer and medical device regulations in Regional and Local markets. The team partners closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance
• Provide support to internal/external business stakeholders
• Interpret scientific information and assess whether technical arguments are articulated clearly
• Act as primary contact with regulatory authorities with limited supervision
• Actively participate in team activities
• Participate in peer to peer coaching as necessary

Skills

• Working knowledge of dossier section authoring and compilation for submissions
• Thorough understanding of regulatory processes and information systems.
• Self-motivated and capable of working independently with minimal supervision
• Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Command of English language (verbal and written)
• Ability to understand scientific information and assess whether technical arguments are articulated clearly
• Experienced in good documentation practices and requirements for managing regulated records
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Some knowledge of how to create a successful product regulatory strategy
• Operates with a sense of urgency, agility and flexibility
• Demonstrated ability in analytical reasoning and critical thinking skills
• Ability to handle multiple tasks and meet deadlines
• Strong capability to contribute in a team environment
• Ability to support internal/external business stakeholders
• Excellent organizational, interpersonal and communication skills; both oral and written
• Ability to influence others in a positive and effective manner
• Capacity to react quickly and decisively in unexpected situations
• Focused ability to influence operational excellence and performance metrics
• Risk adverse where needed with the ability to identify potential solutions to complex problems
   

Qualifications

Bachelor degree preferred (or equivalent education and experience).
Minimum of 3 years Regulatory Affairs experience or relevant experience in a regulated environment.

Skilled in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project).
Knowledge of country regulations (medical device and pharma), post market surveillance, ISO and IEC.

This position may be available in the following location(s): US - Remote

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.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $70,000.00 and $115,000.00.  The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors.

U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

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 + Lomb's Job Offer Fraud Statement.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

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.