Regulatory Affairs Specialist II

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.

Responsibilities

Global – Responsible for 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.

Act as primary contact with regulatory authorities with supervision.

Requirements

Minimum Associate degree, Bachelor degree preferred or equivalent

Minimum of 1.5 years Regulatory Affairs experience or relevant experience in a regulated environment

Some skills in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)

Some knowledge of country regulations (med device, IVDs ( In vitro diagnostics ), and pharma), post-market surveillance, ISO and IEC

Command of English language (verbal and written)

Working knowledge of dossier section authoring and compilation for submissions

Thorough understanding of regulatory processes and information systems

Other Skills

Excellent communication / interpersonal and writing

Self-motivated and capable of working independently with minimal supervision

Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies

Ability to work and contribute to a team environment

Ability to understand scientific information and start to assess whether technical arguments are articulated clearly

Knowledge of good documentation practices

Operates with a sense of urgency

Demonstrated ability in analytical reasoning and critical thinking skills

Ability to handle multiple tasks and meet deadlines

Ability to support internal/external business stakeholders

Demonstrated ability to contribute to a continuous learning and process improvement environment

Capacity to react quickly and decisively in unexpected situations

This position may be available in the following location(s): [[locationobj]]

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 $65,000 to $95,000. 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 Lombs Job Offer Fraud Statement (https://performancemanager.successfactors.eu/doc/custom/BauschLomb/Bauschjobpostingstatement.docx) .

Our Benefit Programs: Employee Benefits: Bausch Lomb (https://www.bausch.com/careers/benefits/)

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.