Senior Regulatory Affairs Program Manager

The Senior Regulatory Affairs Program Manager leads complex cross-functional regulatory initiatives from strategy through execution, ensuring products meet global regulatory requirements and are delivered in alignment with business objectives and launch timelines. The role partners closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to develop and implement regulatory strategies, manage submission activities and timelines, and support successful product approvals and lifecycle management worldwide.

Requirements

• Bachelor’s degree in sciences, business, project management or a related field
• 8+ years of relevant progressive experience
• 5+ years in leadership preferred
• 6+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry is preferred
• 5+ years managing complex, multi-regional regulatory programs is preferred

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) includes: 11 Holidays, Exempt Employees are eligible for Unlimited PTO, Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day