Senior Principal Regulatory Affairs Specialist

Senior Principal Regulatory Affairs Specialist - Pharmaceutical Strategy Apply for the Senior Principal Regulatory Affairs Specialist - Pharmaceutical Strategy role at Synergetics. 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 worldwide. Our mission is to help people see better, live better. Objectives Lead and execute global regulatory strategies for development programs and marketed products across CMC, clinical, labeling, and adpromo domains. Serve as a strategic advisor to project teams, ensuring regulatory compliance, influencing stakeholders, and optimizing business outcomes. Responsibilities Formulate, lead, and drive integrated regulatory strategies across CMC, 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 (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 Bachelors degree or equivalent; Masters degree preferred. Minimum of 8 years of recent experience in strategic pharmaceutical Regulatory Affairs; recent pharmacuetical background required. Must have recent experience with IND and NDA submissions. 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 successful regulatory submissions and increase approval probability. 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 effectively. Demonstrated ability to contribute to continuous learning and process improvement. Excellent communication skills, both oral and written. Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk. Advanced project management and leadership experience with influencing team members beyond reporting structure. Ability to work with key national opinion leaders and advisory boards. Benefits Medical, Dental, Eye Health, Disability and Life Insurance begins on hire date. 401(k) Plan with company match and ongoing contribution. Paid time off vacation (3 weeks), 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. Location: Remote, United States. 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. #J-18808-Ljbffr