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CSL

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

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in leading regulatory initiatives and managing complex projects within the pharma/biotech industry, with a strong focus on biologics and regulatory affairs. Proven ability to mentor project managers and oversee global regulatory submissions while ensuring alignment with strategic priorities.

Highest-signal resume keywords
Project ManagementRegulatory AffairsGlobal Regulatory Submission ProcessesBiologics ExpertiseCross-Functional Project Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Project ManagementRegulatory SubmissionsDrug Development LifecycleProject GovernancePortfolio Management
Soft Skills
MentoringTraining
Certifications & Qualifications
PMP Certification
Industry Keywords
PharmaBiotechLife SciencesGlobal Submission Management ProcessMatrix Environment

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