Principal Scientist, CMC Regulatory Affairs

Johnson & Johnson · Warsaw, Poland

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RegulatoryFull-timeCompany career page

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Role summary

Johnson & Johnson seeks a Principal Scientist in CMC Regulatory Affairs to lead chemistry, manufacturing, and control regulatory strategy for synthetic drugs and delivery devices. The role encompasses pre- and post-approval activities, regulatory dossier preparation, and health authority interactions across the product lifecycle.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-04). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences
Minimum 8+ years of pharmaceutical or healthcare industry experience
Master's, Ph.D., or Pharm.D. degree preferred
Demonstrated ability to develop regulatory strategies and understand product development
Strong written and verbal communication skills with cross-functional collaboration experience
Knowledge of global health authority regulations, guidance documents, and submission routes
Prior experience interacting with health authorities under senior supervision

What you'll be doing

Serve as CMC regulatory lead on development teams, providing expertise to support global product development
Develop and execute global CMC regulatory strategy for synthetic drugs and delivery devices
Lead preparation of regulatory dossiers for health authority submissions
Develop CMC regulatory strategy for health authority responses and ensure lifecycle compliance
Escalate regulatory issues affecting registration and product lifecycle management to management

Compensationzł205,000.00 - zł354,200.00 base

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Date posted1 day ago

Last source checkToday

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