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Associate Director, Regulatory Affairs, CMC

ComplianceComplianceFull TimeRemoteSeniorTeam 501-1,000H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

72 days ago

Salary

0

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

Associate Director, Regulatory Affairs, CMC

AskBio Inc.

• Support innovative, comprehensive regulatory CMC strategies and associated timelines for assigned projects to ensure timely global registration of Company’s product candidates in gene therapy • Manage and implement planning, authoring and submission of high-quality CMC‑related sections of briefing documents and clinical trial applications in the US, EU and ROW • Provide general operational support to RA CMC team across all programs, including submission management, regulatory project management, and Veeva technical support • Prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections • Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals • Support the development of regulatory processes and standards • Ensure operational alignment and on-time completion of all registration-directed activities through close collaboration with Project Management colleagues and senior management • Partner with Quality Assurance colleagues to ensure regulatory compliance with applicable local and international laws and regulations, as well as industry standards.

Job Requirements

  • Bachelor’s degree in a scientific or engineering discipline
  • 8+ years of experience in CMC drug development (may include experience in Regulatory Affairs CMC, process/analytical development, GMP Quality Assurance, or MSAT)
  • At least 3 years in a Regulatory Affairs CMC role
  • Proven record of contributions to successful IND/CTA and NDA/BLA/MAA submissions and approvals
  • Possess extensive experience compiling investigational submissions such as but not limited to US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

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