Associate Director, Regulatory Project Manager

CSL

Leading global regulatory project management for CSL Behring's biotherapeutics portfolio. Overseeing submissions and cross-functional collaboration to drive operational excellence.

Posted 7/6/2026full-timeWaltham • Massachusetts, Pennsylvania • 🇺🇸 United StatesSenior💰 $170,000 - $210,000 per yearWebsite

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Lead end-to-end project management of regulatory initiatives and improvement projects (initiation through closure) within budget, scope, and timelines.
Oversee regulatory submissions per CSL’s Global Submission Management Process.
Manage improvement projects portfolio in alignment with GRA strategy and executive priorities.
Mentor junior project managers and support training on submission processes and tools.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences or Business required; advanced degree (MSc, PhD, MBA) and PMP certification preferred.
7+ years of experience in pharma/biotech industry with a focus on biologics and regulatory affairs.
7+ years’ experience managing global, cross-functional projects in a matrix environment.
Strong knowledge of global regulatory submission processes, drug development lifecycle, and project governance.
Demonstrated success in delivering complex projects on time and within scope.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Project ManagementRegulatory SubmissionsDrug Development LifecycleProject GovernancePortfolio Management

Soft Skills

MentoringTraining

Certifications

PMP Certification