Collabera
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Regulatory Affairs Associate
role at
Collabera .
Hiring: Pharmaceutical/Medical Device | Resumes to siddhi.kadakia@collabera.com (No C2C/Vendors)
Base pay range $34.00/hr - $38.00/hr
Work Details Industry:
Biotechnology / Pharmaceutical Research
Job Title:
Regulatory Affairs Associate I
Duration:
12 Months Contract
Location:
North Chicago, IL 60064 - Hybrid (Tuesday-Thursday onsite preferredbr> Work Schedule:
Monday-Friday | 8:00 AM - 5:00 PM | 40 hours/week
Pay Range:
$34.00 to $38.00 an hour
Purpose The
Regulatory Affairs Associate I
supports regulatory submission activities for marketed pharmaceutical products, with a primary focus on Chemistry, Manufacturing, and Controls (CMC) documentation. This role is responsible for authoring, compiling, and managing CTD Module 3 content for product variations and regulatory filings. The associate partners with cross‑functional teams to ensure regulatory dossiers are complete, accurate, compliant, and submitted on time, with minimal oversight.
Education
Bachelor’s degree in Chemical Sciences, Biological Sciences, or a closely related scientific discipline (required)
1-2 years of experience in the pharmaceutical industry (required)
1-2 years of cross‑functional project management experience (required)
Prior experience in Regulatory Affairs, R&D, or Manufacturing with exposure to CTD Module 3 (CMC) content (preferred)
Responsibilities
Author, compile, and manage CMC sections (CTD Module 3) for marketed product variations.
Ensure regulatory documents meet structural, formatting, and content requirements.
Manage assigned regulatory projects to ensure accuracy, completeness, and on‑time delivery.
Partner with Regulatory Affairs CMC Project Leads to develop submission strategies and timelines.
Coordinate cross‑functional contributors to support regulatory filings.
Facilitate project team and document review meetings independently.
Track changes in project scope and adjust priorities as needed.
Support regulatory responses and dossier updates as required.
Maintain awareness of current regulatory best practices and internal regulatory systems.
Ensure submissions are compliant, file‑ready, and acceptable to regulatory agencies.
Skills
Strong understanding of CMC documentation requirements and CTD structure.
Experience authoring and compiling regulatory submission content.
Familiarity with U.S. and international regulatory requirements for pharmaceutical dossiers.
Experience working with electronic document management systems.
Strong written and verbal communication skills.
Ability to independently manage multiple projects and timelines.
Detail‑oriented with a high focus on accuracy, compliance, and file‑ability.
Comfortable facilitating cross‑functional meetings and driving deliverables.
Benefits The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term disability insurance, short‑term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility.
Seniority level
Entry level
Employment type
Contract
Job function
Legal
Referrals increase your chances of interviewing at Collabera by 2x.
Get notified about new Regulatory Affairs Associate jobs in North Chicago, IL.
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Regulatory Affairs Associate
role at
Collabera .
Hiring: Pharmaceutical/Medical Device | Resumes to siddhi.kadakia@collabera.com (No C2C/Vendors)
Base pay range $34.00/hr - $38.00/hr
Work Details Industry:
Biotechnology / Pharmaceutical Research
Job Title:
Regulatory Affairs Associate I
Duration:
12 Months Contract
Location:
North Chicago, IL 60064 - Hybrid (Tuesday-Thursday onsite preferredbr> Work Schedule:
Monday-Friday | 8:00 AM - 5:00 PM | 40 hours/week
Pay Range:
$34.00 to $38.00 an hour
Purpose The
Regulatory Affairs Associate I
supports regulatory submission activities for marketed pharmaceutical products, with a primary focus on Chemistry, Manufacturing, and Controls (CMC) documentation. This role is responsible for authoring, compiling, and managing CTD Module 3 content for product variations and regulatory filings. The associate partners with cross‑functional teams to ensure regulatory dossiers are complete, accurate, compliant, and submitted on time, with minimal oversight.
Education
Bachelor’s degree in Chemical Sciences, Biological Sciences, or a closely related scientific discipline (required)
1-2 years of experience in the pharmaceutical industry (required)
1-2 years of cross‑functional project management experience (required)
Prior experience in Regulatory Affairs, R&D, or Manufacturing with exposure to CTD Module 3 (CMC) content (preferred)
Responsibilities
Author, compile, and manage CMC sections (CTD Module 3) for marketed product variations.
Ensure regulatory documents meet structural, formatting, and content requirements.
Manage assigned regulatory projects to ensure accuracy, completeness, and on‑time delivery.
Partner with Regulatory Affairs CMC Project Leads to develop submission strategies and timelines.
Coordinate cross‑functional contributors to support regulatory filings.
Facilitate project team and document review meetings independently.
Track changes in project scope and adjust priorities as needed.
Support regulatory responses and dossier updates as required.
Maintain awareness of current regulatory best practices and internal regulatory systems.
Ensure submissions are compliant, file‑ready, and acceptable to regulatory agencies.
Skills
Strong understanding of CMC documentation requirements and CTD structure.
Experience authoring and compiling regulatory submission content.
Familiarity with U.S. and international regulatory requirements for pharmaceutical dossiers.
Experience working with electronic document management systems.
Strong written and verbal communication skills.
Ability to independently manage multiple projects and timelines.
Detail‑oriented with a high focus on accuracy, compliance, and file‑ability.
Comfortable facilitating cross‑functional meetings and driving deliverables.
Benefits The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long‑term disability insurance, short‑term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility.
Seniority level
Entry level
Employment type
Contract
Job function
Legal
Referrals increase your chances of interviewing at Collabera by 2x.
Get notified about new Regulatory Affairs Associate jobs in North Chicago, IL.
#J-18808-Ljbffr