Senior Principal Regulatory Affairs Specialist

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 worldfrom 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.
**Objectives:**
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, adpromo areas.

Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing key stakeholders, and optimizing business outcomes.
**Responsibilities:**
+ Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo domains.
+ Provide technical expertise and regulatory direction to project teams throughout the product lifecycle.
+ Proactively communicate strategy, risks, and critical issues to stakeholders and senior leadership.
+ Influence internal and external stakeholders, including Key Opinion Leaders (KOLs), to achieve strategic objectives.
+ Serve as primary regulatory point of contact with Health Authorities and manage ongoing relationships.
+ Participate in assigned due diligence activities for business development and acquisitions.
+ Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
+ Plan, author, review, and coordinate high-quality submission components (including complex variations such as PAS, group supplements, site transfers, and supplier changes) for IND, NDA, ANDAs and amendments/supplements.
+ Serve as RA representative on facility/site Local Change Management Boards.
+ Ensure operational excellence, compliance, and timely execution of deliverables.
+ Drive regulatory strategies for clinical, non-clinical, CMC and labeling development plans, ensuring alignment with global requirements.
+ Provide guidance on risk assessment, clinical trial design implications, and regulatory pathways.
+ Support interactions with Health Authorities for development programs.
+ Ensure high-quality submissions by proofreading and checking documents for accuracy and consistency.
+ Contribute to continuous learning, process improvement, and knowledge-sharing initiatives.
+ Mentor and coach team members in regulatory strategy and submission excellence.
+ Monitor and report on performance metrics to drive operational effectiveness.
+ Participate in external forums, regulatory boards, and committees to influence regulatory policies and industry standards.
**Qualifications:**
+ Bachelor degree or equivalent, Master degree preferred
+ Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment
+ Ability to interpret Regulatory Authority policies, regulations and guidances and correctly apply them as appropriate
+ Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
+ Ability to take innovative ideas to promote a successful regulatory submission and increase the probability of regulatory approval
+ Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
+ Strong interpersonal skills with the ability to influence others in a positive and effective manner
+ Demonstrated ability to contribute to a continuous learning and process improvement environment
+ Excellent communication skills; both oral and written
+ Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business
+ Capacity to react quickly and decisively in unexpected situations
+ Ability to influence external regulatory stakeholders and shape the external regulatory environment
+ Advanced Project Management / leadership experience with the ability to influence team members that are not within their reporting structure
+ The ability to work with key national opinion leaders, and advisory boards
**We offer competitive salary & excellent benefits including:**
+ Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
+ 401K Plan with company match and ongoing company contribution
+ Paid time off vacation (3 weeks - prorated upon hire), floating holidays and sick time
+ Employee Stock Purchase Plan with company match
+ Employee Incentive Bonus
+ Tuition Reimbursement (select degrees)
+ Ongoing performance feedback and annual compensation review
This position may be available in the following location(s): [[location_obj]]
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 $120,000 to $180,000.

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 readBausch + Lomb's Job Offer Fraud Statement (https://performancemanager.successfactors.eu/doc/custom/BauschLomb/Bausch_job_posting_statement.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.

Required Skill Profession

Other General