Stark Pharma
CMC Regulatory Specialist
Company:
Stark Pharma
Location:
North Chicago, IL (Hybrid)
Experience:
1-2 years
Contract Duration:
12+ Months (possible extension)
Requirement:
LinkedIn profile required
Role Overview:
The CMC Regulatory Affairs Associate will support regulatory submission activities with a strong focus on Chemistry, Manufacturing, and Controls. This role is hands‑on and centered on authoring, reviewing, and managing Module 3 content for CTD and eCTD submissions within a pharmaceutical environment.
Key Responsibilities
Author, compile, and maintain Module 3 (CMC) sections for CTD and eCTD submissions
Support regulatory filings including INDs, NDAs, ANDAs, BLAs, and post‑approval changes
Ensure CMC documentation aligns with ICH guidelines, with emphasis on ICH M4Q
Collaborate with CMC, analytical, process development, and quality teams
Review technical and scientific data and convert it into regulatory‑ready content
Support global regulatory submissions and health authority interactions as needed
Maintain accurate and compliant regulatory documentation and records
Assist in preparing responses to regulatory agency questions related to CMC
Must‑Have Qualifications (Deal Breakers)
1-2 years of experience in the pharmaceutical industry
Strong hands‑on experience in CMC regulatory activities
Direct experience authoring Module 3 content
Working knowledge of CTD and eCTD submission formats
Solid understanding of ICH guidelines, specifically ICH M4Q
Bachelor's or Master's degree in Chemical Sciences, Biological Sciences, or a related field
Strong written and verbal communication skills
Nice‑to‑Have Qualifications
Background in analytical chemistry or process chemistry
Experience supporting global regulatory submissions
Exposure to Technical File documentation
Medical device experience only if combined with pharmaceutical CMC experience
Not a Fit For
Labeling‑focused regulatory roles
Publishing‑only profiles without CMC authoring experience
Operations or coordination‑only regulatory positions
Seniority level:
Entry level
Employment type:
Full‑time
Job function:
Legal
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Stark Pharma
Location:
North Chicago, IL (Hybrid)
Experience:
1-2 years
Contract Duration:
12+ Months (possible extension)
Requirement:
LinkedIn profile required
Role Overview:
The CMC Regulatory Affairs Associate will support regulatory submission activities with a strong focus on Chemistry, Manufacturing, and Controls. This role is hands‑on and centered on authoring, reviewing, and managing Module 3 content for CTD and eCTD submissions within a pharmaceutical environment.
Key Responsibilities
Author, compile, and maintain Module 3 (CMC) sections for CTD and eCTD submissions
Support regulatory filings including INDs, NDAs, ANDAs, BLAs, and post‑approval changes
Ensure CMC documentation aligns with ICH guidelines, with emphasis on ICH M4Q
Collaborate with CMC, analytical, process development, and quality teams
Review technical and scientific data and convert it into regulatory‑ready content
Support global regulatory submissions and health authority interactions as needed
Maintain accurate and compliant regulatory documentation and records
Assist in preparing responses to regulatory agency questions related to CMC
Must‑Have Qualifications (Deal Breakers)
1-2 years of experience in the pharmaceutical industry
Strong hands‑on experience in CMC regulatory activities
Direct experience authoring Module 3 content
Working knowledge of CTD and eCTD submission formats
Solid understanding of ICH guidelines, specifically ICH M4Q
Bachelor's or Master's degree in Chemical Sciences, Biological Sciences, or a related field
Strong written and verbal communication skills
Nice‑to‑Have Qualifications
Background in analytical chemistry or process chemistry
Experience supporting global regulatory submissions
Exposure to Technical File documentation
Medical device experience only if combined with pharmaceutical CMC experience
Not a Fit For
Labeling‑focused regulatory roles
Publishing‑only profiles without CMC authoring experience
Operations or coordination‑only regulatory positions
Seniority level:
Entry level
Employment type:
Full‑time
Job function:
Legal
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