Regulatory Affairs Program Manager

The Regulatory Affairs Program Manager leads cross-functional regulatory projects from strategy through execution, ensuring that all products meet global regulatory requirements and are launched on schedule. This role partners closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission timelines, and drive successful product approvals worldwide.

Requirements

• Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies.
• Function as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives.
• Coordinate cross-functional project teams, ensuring alignment with regulatory objectives and strategy.
• Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards.
• Identify risks early, develop mitigation plans, and resolve issues that could impact timelines or approvals.
• Foster a culture of continuous improvement and regulatory excellence.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO)