Hope Through Rigorous Science

Executive Director, Regulatory CMC

ComplianceComplianceFull TimeRemoteTeam 201-500Since 2015H1B SponsorCompany Site LinkedIn

Location

United States

Posted

26 days ago

Salary

$320K - $350K / year

Postgraduate Degree15 yrs expEnglish

Job Description

• Provide strategic and operational leadership for global CMC regulatory activities across development and (as applicable) commercial products • Partner closely with CMC, Quality, Technical Operations, Clinical, and Regulatory Affairs leadership to define regulatory CMC strategy, ensure high-quality submissions, and enable product development, licensure, and lifecycle management. • Lead preparation, review, and approval of CMC sections for regulatory submissions (Module 3, quality overall summaries, responses to information requests) • Develop and manage CMC-related briefing packages, meeting requests, and responses for global health authority interactions (FDA, EMA, MHRA, PMDA, etc.) • Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.

Job Requirements

Advanced degree in a relevant scientific discipline (PhD strongly preferred; MS/BS with significant experience considered)
Typically 12–15+ years of relevant experience in CMC regulatory affairs within biotech/pharma (biologics, small molecules, cell/gene therapy, or combination products—tailor as needed)
Demonstrated success leading CMC strategy and authoring/reviewing Module 3 for major global submissions (IND/CTA and at least one marketing application strongly preferred)
Deep knowledge of global CMC regulations and guidances (ICH Q-series, regional requirements, post-approval change frameworks)
Proven ability to lead cross-functional teams and influence senior stakeholders in a matrix environment
Excellent writing, communication, and executive presentation skills
You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.