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Senior Consultant, CMC

REMOTE, DC 00000

Posted: 02/01/2023 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 524479 Is job remote?: Yes Country: United States

Job Description


Target salary: $175 - $190k base

**salary will be commensurate with experience**

Job Description
The Senior Consultant, CMC is responsible for producing high quality CMC related Module 3 sections for INDs, License applications and Briefing Documents. This role will serve as primary author of Module 3/CMC documents with the view of an FDA product reviewer for successful filings. We are looking for someone to have experience with small molecule and combo drug project experience.

Essential Functions
  • Through review and assessment of provided CMC, Module 3 related documents, the Senior Consultant, CMC regulatory will be responsible for providing guidance to both internal and external stakeholders.
  • The Senior Consultant, CMC regulatory will also assist the SVP Global Regulatory Issues and Head of CMC to provide strategic guidance to clients regarding appropriateness of CMC changes, and risk mitigation approaches and assessment of said changes for implications to regulatory filings.
  • Provide high quality and excellent consulting to all PPG clients and prospective clients.
  • Author and or review with the view of a FDA product reviewer
  • Listen and provide creative forward-thinking solutions yet within the boundaries of regulations.
  • Ensure up to speed on current and changing CMC regulatory guidance’s, and regulations (within FDA, ICH and globally).
  • Understanding of regulatory requirements for CMC a must.
  • Significant breadth and depth of regulatory experience that includes hands on de novo authoring and review of CMC (Module 3) submissions/filings.
  • Have the passion, drive, and motivation to strive for excellence and high quality that exemplifies and cultivates.
  • Grow as a consultant and present at meetings, network at meetings, and spread the word of PPG’s expertise.

Qualifications
  • Preferred: Master’s degree or PhD but Bachelor’s is at least required
  • At least 3-5 years hands-on proven CMC-Regulatory experience in both pharmaceutical industry (small to mid-size preferred).
  • Experience as CMC regulator on filing of INDs, CTX, CTAs, NDAs, BLAs pre and MAA’s as well as amendments, supplements and variations preferred.
  • Understanding of basic regulatory requirements for clinical and non-clinical are a plus.
  • Industry Regulatory, CMC, quality, and operational experience is a must.
** CO/NYC candidates might not be considered**
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