Director, CMC Regulatory (REF8275H)

Job Description

The Director, CMC Regulatory is responsible for providing high quality, hands-on, excellent consulting to clients and prospective clients through review and assessment of provided CMC, Module 3 documents; through authoring relevant module 3 sections for IND, license applications, and Briefing packages for regulatory authority meetings.

The Director, CMC regulatory will also provide strategic guidance to clients regarding the appropriateness of CMC changes, and risk mitigation approaches, and assessment of said changes to implications to regulatory filings.

• Primary author and/or review Module 3/CMC documents with the view of an FDA product reviewer for successful filings.
• CMC lead on assigned projects to provide creative forward-thinking solutions within regulatory boundaries to clients, vendors, and colleagues
• Provide strategic CMC regulatory guidance to all stakeholders with a view towards achieving successful negotiations with FDA and global health authorities.
• Consult, present, and network at meetings (internal and external) to share expertise.
• Ensure up to speed on current and changing CMC regulatory guidance, and regulations (within FDA, ICH, and globally).

Qualifications

• Minimum: Bachelor’s degree
  • Preferred: Master’s degree or PhD
• Minimum 10 years hands-on proven CMC-Regulatory experience in both pharmaceutical industry (small to mid-size preferred) and consulting with PhD or 15 years’ experience with Bachelor’s degree or higher.
• Significant breadth and depth of global regulatory experience that includes creative strategy development, author and reviewer of CMC submissions/filings, and lead CMC regulator on filing of INDs, CTAs, NDAs, BLAs and MAA’s as well as amendments, supplements, and variations.
• Proven history of successful negotiations with the FDA and global health authorities; negotiations to approval important but not essential.
• Solid examples of building consensus and being influential with internal and external stakeholders.
• Industry Regulatory, CMC, quality, operational experience a must
• Strong management experience leading and mentoring Regulatory projects and mentoring clients or team members.
• Understanding of basic regulatory requirements for clinical and non-clinical are a plus.
• Prefer 1-2 years independent consulting experience
• Significant breadth and depth of global regulatory experience that includes creative strategy development, author and reviewer of CMC submissions/filings, and lead CMC regulator on filing of INDs, CTAs, NDAs, BLAs and MAA’s as well as amendments, supplements and variations.
• Proven history of successful negotiations with the FDA and global health authorities.
• Strong management experience leading and mentoring Regulatory projects and mentoring clients or team members.
• Excellent verbal and written communication skills with the ability to engage, negotiate, influence, and gain consensus across multiple functions.
• Proven hands-on Industry Regulatory, CMC, quality, and operational experience in the pharmaceutical/biotechnology industry.
• Proficient in Microsoft Office.
• Highly organized with the ability to execute and deliver on multiple tasks and projects within given deadlines.
• Detail-oriented with a focus on quality.

Additional Information

• All candidates must be legally eligible to work in the United States.
• We are an equal opportunity employer. M/F/D/V
• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.