Senior Principal Regulatory Affairs Specialist ...

@ Bausch + Lomb

About Bausch + Lomb

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions. With over 400 products and a 170-year legacy, the company serves customers across all life stages.

Objectives

Lead and execute global regulatory strategies for development programs and marketed products across CMC, clinical/non-clinical, labeling, and adpromo areas. Serve as a strategic advisor to project teams, ensuring regulatory compliance and optimizing business outcomes.

Responsibilities

• Formulate and drive integrated regulatory strategies across multiple domains.
• Provide technical expertise and regulatory direction through product lifecycles.
• Communicate risks and critical issues to stakeholders and senior leadership.
• Influence internal/external stakeholders including Key Opinion Leaders.
• Serve as primary contact with Health Authorities and manage relationships.
• Lead CMC regulatory activities for IND, NDA, ANDA, and BLA submissions.
• Plan, author, review, and coordinate submission components for various regulatory submissions.
• Participate in due diligence for business development and acquisitions.
• Mentor and coach team members in submission excellence.
• Engage in external forums and committees to influence regulatory standards.

Qualifications

Minimum 8 years in strategic pharmaceutical Regulatory Affairs with recent experience in IND and NDA submissions. A Bachelor degree is required; a Master degree is preferred. Candidates must demonstrate a strong understanding of regulatory guidelines, excellent communication, and leadership skills with a proactive approach to strategy and risk management.

Benefits

• Competitive Salary
• Medical, Dental, Eye Health, Disability and Life Insurance effective from hire date
• 401K Plan with company match
• Paid time off including vacation, floating holidays, and sick time
• Employee Stock Purchase Plan, Incentive Bonus, Tuition Reimbursement
• Ongoing performance feedback and annual compensation review

Location & Eligibility

This position is available for U.S. candidates on a remote basis. Applicants must be authorized to work for any employer in the U.S. (Visa sponsorship is not available).

Key Skills/Competency

• Regulatory Strategy
• CMC
• IND/NDA/Submissions
• Compliance
• Risk Management
• Stakeholder Engagement
• Technical Expertise
• Leadership
• Project Management
• Process Improvement