Bausch + Lomb
Senior Principal Regulatory Affairs Specialist
Bausch + Lomb, Boston, Massachusetts, us, 02298
Overview
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight. Our mission is helping you see better, to live better. We have a portfolio of over 400 products, a global footprint with approximately 13,000 employees, and a presence in about 100 countries. We are committed to advancing eye health through research, development, manufacturing, and commercial activities. Objectives:
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, and promotional 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, and 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 for IND, NDA, ANDAs, and amendments/supplements (including PAS, group supplements, site transfers, and supplier changes). 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 apply them appropriately. Strong business acumen with the ability to see business drivers outside of Regulatory Affairs. Ability to promote innovative ideas to improve regulatory submissions and increase the probability of regulatory approval. Ability to critically review detailed scientific information and assess whether technical arguments are well-supported by data. Strong interpersonal skills with the ability to influence others positively. Demonstrated ability to contribute to continuous learning and process improvement. Excellent written and oral communication skills. Ability 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 outside reporting lines. Experience collaborating with national opinion leaders and advisory boards. Benefits
Competitive salary and excellent benefits including medical, dental, eye health, disability, and life insurance from hire date. 401(k) plan with company match and ongoing contribution. Paid time off including vacation (3 weeks, prorated), 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 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.
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Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight. Our mission is helping you see better, to live better. We have a portfolio of over 400 products, a global footprint with approximately 13,000 employees, and a presence in about 100 countries. We are committed to advancing eye health through research, development, manufacturing, and commercial activities. Objectives:
Lead and execute global regulatory strategies for development programs and marketed products across CMC and clinical/non-clinical, labeling, and promotional 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, and 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 for IND, NDA, ANDAs, and amendments/supplements (including PAS, group supplements, site transfers, and supplier changes). 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 apply them appropriately. Strong business acumen with the ability to see business drivers outside of Regulatory Affairs. Ability to promote innovative ideas to improve regulatory submissions and increase the probability of regulatory approval. Ability to critically review detailed scientific information and assess whether technical arguments are well-supported by data. Strong interpersonal skills with the ability to influence others positively. Demonstrated ability to contribute to continuous learning and process improvement. Excellent written and oral communication skills. Ability 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 outside reporting lines. Experience collaborating with national opinion leaders and advisory boards. Benefits
Competitive salary and excellent benefits including medical, dental, eye health, disability, and life insurance from hire date. 401(k) plan with company match and ongoing contribution. Paid time off including vacation (3 weeks, prorated), 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 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.
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