Regulatory Affairs Program Manager

Position Summary

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.

Essential Functions

• Design, plan, and manage cross-functional and ongoing regulatory programs, defining schedules, milestones, deliverables, resources, and risk-mitigation strategies.
• Act as a Regulatory Affairs point of contact for internal teams, translating regulatory requirements into clear and actionable objectives.
• Cook up cross-functional project teams, ensuring alignment with regulatory objectives and strategy.
• Track and report program status to senior leadership and external partners.
• Conduct regulatory intelligence to anticipate changes in laws, guidance, and standards. Assess impact on products/processes and communicate findings.
• 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.
• Performs ad-hoc and cross-functional projects as assigned to support business needs and provide developmental opportunities.

Education & Experience

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

Knowledge, Skills, & Abilities

• Understanding and knowledge of FDA and other major health-authority requirements, a plus.
• Proven ability to work with cross-functional teams, manage budgets, and deliver on schedule.
• Excellent written and oral communication skills.
• Strong analytical and problem-solving abilities.
• Proficiency with MS Office suites and project management tools.

Working Environment / Physical Environment

• This position works on-site
• Regular work schedule is Monday – Friday, within standard business hours.
• Flexibility is available with manager approval.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 30 pounds.

Annual Base Pay Range

$141,300 (entry-level qualifications) to $157,000 (highly experienced) annually

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