Regulatory Affairs Program Manager

Role 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.

Responsibilities

• 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. 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.

Qualifications

• Required: Bachelor’s degree in sciences, business, project management or a related field with 7+ years of relevant progressive experience.
• Preferred: 5+ years of regulatory affairs experience in the pharmaceutical, biologics, or medical device industry.
• Preferred: 3+ years managing complex, multi‑regional regulatory programs.

Skills

• 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.

Education

• Bachelor’s degree in sciences, business, project management or a related field.

Additional Requirements

• This position works on-site.
• Regular work schedule is Monday – Friday, within standard business hours; flexibility 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.