Remote CMC Regulatory Strategy Consultant (Biologics)

Parexel; California; Hybrid; USD 130.000 - 180.000; Vollzeit

Zusammenfassung

Parexel is seeking a CMC Strategy Senior Associate / Consultant to lead and contribute to regulatory strategies for biologics and vaccines, spanning US, EU, and beyond.

You will author and review CMC documentation, support global submissions, and perform dossier gap analyses, collaborating with Regulatory, Quality, Manufacturing, and client teams to ensure compliant lifecycle management and timely submissions. This role offers remote work with global exposure.

Qualifikationen

• 3+ years in CMC Regulatory Affairs or CMC Strategy for Senior Associate; 5+ years for Consultant.
• Hands-on with commercial biologics or vaccines.
• Strong knowledge of FDA/EMA and international regulatory requirements.
• Experience with global submission management.
• Expertise in authoring/reviewing CMC Modules 1-3 and gap analyses.

Aufgaben

• Lead and contribute to CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes.
• Author and review high-quality CMC documentation (Modules 1-3) for global submissions.
• Support and lead global submissions (US, EU, and beyond) from planning through execution.
• Perform CMC dossier gap analyses and provide strategic recommendations.
• Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders.
• Act as a key contributor within a dedicated client team with strong relationships.
• Ensure submissions meet global regulatory expectations with precision and excellence.

Kenntnisse

CMC strategy

Module 1-3 authoring

Global submissions

Stakeholder mgmt

Communication

Tools

Veeva Vault

Jobbeschreibung

Parexel is seeking a CMC Strategy Senior Associate / Consultant to lead and contribute to regulatory strategies for biologics and vaccines, spanning US, EU, and beyond.

You will author and review CMC documentation, support global submissions, and perform dossier gap analyses, collaborating with Regulatory, Quality, Manufacturing, and client teams to ensure compliant lifecycle management and timely submissions. This role offers remote work with global exposure.