Regulatory Affairs Associate - CMC (Hybrid)

Contract: North Chicago, Illinois, US

Salary Range: 35.00 - 42.00 | Per Hour

Job Code: 360803

End Date: 2025-05-10

Days Left: 18 days, 17 hours left

Position Details:
Job Title: Regulatory Affairs Associate - CMC (Hybrid) 
Location: North Chicago, IL 60064
Duration: 18 months [+ Possibilities of extension]
Pay Range: $35-$42/hr
 
Open for candidates willing to relocate on own expenses
 
Top 3-5 skills, experience or education required for this position:
  • Bachelors Degree: Chemistry/ Biology/ Pharmacy/ Engineering/ Other Related Subject
  • 2-4 years CMC Regulatory experience
  • Preferred Experience: US/ EU Post approval variation support; Change Management Experience; International Regulatory Strategy for on market products
Job Duties:
  • Working with technical team to prepare regulatory filing dossiers
  • Potentially assessing changes for regulatory impact
  • Document management system responsibilities
  • Attend GRPT as needed
  • Attend Operations Brand Teams as needed
  • The Senior Associate, RA CMC works with internal and external partners in order to deliver products to patients. 
  • Prepares CMC regulatory strategies that enable first pass approvals under management supervision. 
  • Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations under management supervision. 
  • Builds and maintains relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. 
  • Represents RA CMC on product development and life-cycle management teams.
  • Prepares CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.
  • Analyzes and interprets information, that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
  • Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.
  • Responds to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.
  • Manages products and change control with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
  • May represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions Stays abreast of regulatory procedures and changes in the regulatory climate. Maintains awareness of legislation and current developments within specific area of business.
Required Education:
  • Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
 
Preferred Education:
  • Relevant advanced degree preferred. Certification a plus.
 
Required Experience:
  • 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management.
  • Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing.
  • Experience working in a complex and matrix environment.
  • Strong oral and written communication skills.
 
 
Job Requirement
  • CMC
  • Chemistry Manufacturing Control
  • Module 3
  • Regulatory Affairs
  • CMC modules
  • Regulatory Submissions
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Niharika Shrivastava
  • niharika.shrivastava@collabera.com
Apply Now
Apply Now
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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