CMC Regulatory Affairs Consultant

Wilmington, DE, US • Posted 1 day ago • Updated 1 day ago
Contract Corp To Corp
Contract W2
12 Months
No Travel Required
Able to Sponsor
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • CMC Regulatory Affairs
  • Regulatory Affairs
  • CMC
  • Regulatory Strategy
  • Regulatory Submissions
  • IND
  • NDA
  • BLA
  • MAA
  • Pre-IND
  • FDA
  • Health Authority
  • Health Authority Interactions
  • CMC Lifecycle Management
  • Change Controls
  • Post-Approval Supplements
  • Variations
  • Renewals
  • Annual Reports
  • Global Regulatory Affairs
  • Large Molecules
  • Small Molecules
  • Biologics
  • Pharmaceutical
  • Biotechnology
  • Drug-Device Combination Products
  • Regulatory Roadmaps
  • Submission Strategy
  • Regulatory Compliance.

Summary

CMC Regulatory Affairs Consultant

Job Type: Contract – 12 Months
Location: Wilmington, DE – Hybrid/Onsite
Work Arrangement: 3 Days Onsite per Week – Non-Negotiable

Required Qualifications

  • Bachelor''s degree or higher in Pharmacy, Chemistry, Biology, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
  • Strong hands-on experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Experience supporting large molecules and/or small molecules.
  • Experience with IND, NDA, BLA, and/or MAA submissions.
  • Experience preparing/reviewing Pre-IND/NDA/BLA meeting requests and briefing packages.
  • Strong experience managing Health Authority interactions and regulatory responses.
  • Experience with FDA and global Health Authorities.
  • Strong understanding of CMC lifecycle management, change controls, supplements, variations, renewals, and annual reports.
  • Ability to independently assess regulatory issues and provide strategic recommendations.
  • Strong stakeholder management and cross-functional collaboration skills.
  • Excellent written and verbal communication skills.
  • Drug-device combination product experience is strongly preferred.
  • Must be able to work onsite in Wilmington, Delaware 3 days per week.
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: 91157029
  • Position Id: 9058705
  • Posted 1 day ago
Contact the job poster
KR

Krish Rao

Recruiter @ SSV Technologies Inc
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