CMC Regulatory Affairs Specialist Small Molecules

Remote • Posted 3 days ago • Updated 2 days ago
Contract W2
Contract Corp To Corp
Remote
Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

  • Small Molecules

Summary

Job Title: CMC Regulatory Affairs Specialist - Small Molecules

Location: Remote

Job Summary:

Responsible for preparing and managing CMC regulatory submissions for small-molecule drug products, ensuring compliance with global regulatory requirements.

Key Responsibilities:

Prepare and review CMC sections for IND, NDA, ANDA, and MAA submissions

Author Module 3 (Quality) documents in eCTD format

Ensure compliance with FDA, EMA, Health Canada, and ICH guidelines

Support manufacturing, analytical, and stability data review

Manage post-approval changes and lifecycle submissions

Coordinate with cross-functional teams (QA, Manufacturing, R&D)

Respond to regulatory authority queries and deficiency letters

Requirements:

10+ years CMC Regulatory Affairs experience

Strong knowledge of small-molecule drug development

Experience with eCTD and Module 3

Knowledge of GMP and global regulatory guidelines

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10236892
  • Position Id: OOJ - 5150-4151-1781103727
  • Posted 3 days ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Remote

2d ago

Easy Apply

Contract, Third Party

Depends on Experience

Remote

30+d ago

Easy Apply

Third Party, Contract

$58.8 - $84

Remote or Nevada

Today

Contract

USD42 - USD52

Remote

Yesterday

Easy Apply

Contract

95000 - 125000

Search all similar jobs