Regulatory Affairs Associate II (CMC)

Contract: North Chicago, Illinois, US

Salary Range: 30.00 - 35.00 | Per Hour

Job Code: 358147

End Date: 2025-02-27

Days Left: 23 days, 12 hours left

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $30 to $35/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

  • Bachelors Degree: Science
  • Regulatory submission documentation creation background
  • Individual is responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.
  • This position will coordinate activities with all functional departments in support of regulatory filings.
  • Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Independently facilitate project team meetings.
  • Superior oral and written communication skills
  • Ability to work cooperatively with all levels and types of global personnel required
  • Experience working with electronic document management systems
  • Ability to work independently. Manage multiple projects simultaneously.
  • Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
  • Detail/accuracy oriented, collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for dossiers
  • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
  • Required Experience: 4 years pharmaceutical. 1-2 years cross-functional project management
  • Preferred Experience: 5 years of pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
  • Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines.
  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
  • Skills for running review meetings for submission documents.
  • Understand CMC expectations including CTD content, structural and formatting requirements.
  • Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs
  • CMC
  • submission
  • CMC dossiers
  • electronic document management
  • CTD Module 3
  • Biotechnology
  • Pharma
  • Pharmaceuticals
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
Apply Now
Apply Now
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