Associate Director, Project Manager - Regulatory Affairs

Responsibilities

• Lead regulatory project management activities aligning deliverables with corporate priorities.
• Partner with Regulatory Leads to manage Global Regulatory Team operations effectively.
• Develop and manage integrated regulatory project timelines reflecting global health authority milestones.
• Oversee planning and execution of major regulatory submissions and maintenance activities.
• Collaborate with cross-functional teams and external partners to ensure timely execution of regulatory deliverables.
• Create regulatory dashboards and reports for visibility on project progress and risks.
• Drive continuous improvement of regulatory processes, tools, and templates to enhance efficiency.

Qualifications

• Bachelor's degree in Life Sciences or a related field; MS, Pharm D, or PhD preferred.
• 8+ years of project management experience in the biotech or pharmaceutical industry; regulatory experience preferred.
• PMP certification strongly preferred.
• Expertise in timeline development and management software, such as Smartsheets and MS Project.
• Strong understanding of global regulatory affairs for rare disease therapies.

Benefits

• Premium health and wellness offerings for employees and their dependents.
• Employee support programs including life insurance and disability benefits.
• Retail plans with employer match available.
• Generous paid time off and work-life balance initiatives.

Pay

$150,000 – $195,000 annually

Schedule

Remote - US based candidates only, no visa sponsorship available