Associate Director, Regulatory Affairs, CMC
Asklepios BioPharmaceutical, Inc. (AskBio)
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
CMC drug developmentregulatory submissionsGMP Quality Assuranceprocess developmentanalytical developmentIND submissionsCTA submissionsNDA submissionsBLA submissionsMAA submissions
Soft Skills
project managementcollaborationcommunicationoperational supportattention to detailproblem-solvingleadershiporganizational skillsinterpersonal skillsregulatory compliance