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Associate Director GRA CMC SaMD & Cybersecurity Specialist

CSLKing Of Prussia, Pennsylvania🇺🇸United StatesPosted 27 Aug 2026

Why This Role Stands Out

This hybrid role offers an exceptional opportunity to shape global regulatory strategy for innovative software as a medical device and cybersecurity within a patient-focused, science-driven company. You'll thrive if you're a strategic thinker with expertise in CMC submissions and a passion for ensuring compliance in the evolving digital health landscape, making a significant impact on patient safety. We encourage you to apply and advance your career in this dynamic and critical area.

Quick Overview

Seniority
Leader
Employment type
Full Time
Work mode
Hybrid
Location
King Of Prussia, Pennsylvania, United States
Stakeholder Management

Job Description

CSL is seeking an Associate Director GRA CMC SaMD & Cybersecurity Specialist to lead global CMC regulatory strategy for software as a medical device and digital components of our biotherapies and vaccines portfolio. You will ensure compliance with evolving global SaMD and cybersecurity regulations, author and review CMC sections of submissions, and partner closely with R&D, Quality, IT, and Product Security. In CSL's patient focused, science driven culture, you will shape secure, compliant digital solutions, represent CSL in health authority interactions, and mentor regulatory colleagues worldwide.

Responsibilities

  • Lead global regulatory CMC strategy for Sa
  • MD and digital components of CSL therapies
  • Ensure cybersecurity and software lifecycle compliance with FDA, EMA, and other health authorities
  • Prepare, review, and maintain CMC sections of regulatory submissions (IND/IMPD, BLA/MAA, variations)
  • Partner with R&D, Quality, IT, and Product Security to embed regulatory and cybersecurity requirements
  • Drive risk assessments and mitigation plans for Sa
  • MD and connected device platforms
  • Monitor evolving global Sa
  • MD and cybersecurity regulations and translate into internal guidance
  • Represent CSL in health authority interactions and answer CMC and cybersecurity queries
  • Support audits and inspections related to Sa
  • MD, data integrity, and cybersecurity controls
  • Mentor junior regulatory staff and promote best practices in digital and Sa
  • MD submissions
  • Contribute to process improvements and global standards for Sa
  • MD and cybersecurity documentation

Required Skills

  • Global regulatory CMC strategy
  • Sa
  • MD regulatory requirements
  • Cybersecurity and data integrity compliance
  • CMC dossier authoring and review
  • FDA, EMA and ICH guidelines
  • Risk management for medical devices and Sa
  • MDIEC 62304 and ISO 14971 frameworks
  • Cross-functional stakeholder management
  • Regulatory submissions (IND/IMPD, BLA/MAA)
  • Audit and inspection readiness

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