Regulatory Program Manager, GeneFab & CDMO
Overview
You will lead quality assurance regulatory programs at GeneFab, a San Francisco biofoundry for cell and gene therapies, driving compliant submissions and lifecycle management for complex products. Working with clients and cross-functional teams, you will shape regulatory strategy from IND to BLA, navigating FDA and EMA requirements. This contract role demands deep CDMO experience and a focus on patient safety. You will own the QA budget and foster a culture of quality across the organization.
What You'll Do10
- 1Prepare and manage IND, NDA/BLA submissions in collaboration with clients, ensuring compliance with global regulations.
- 2Lead regulatory interactions with health authorities, including briefing materials, SME preparation, and follow-up actions.
- 3Negotiate with regulatory agencies to resolve issues and promote proactive engagement.
- 4Communicate regulatory strategy, risks, and mitigations to Regulatory Affairs, program teams, and senior management.
- 5Manage GeneFab's registrations and licenses, including FDA and Oregon Board of Pharmacy.
- 6Develop and implement a quality assurance strategy aligned with organizational goals and regulatory requirements.
- 7Drive continuous improvement in manufacturing quality, collaborating with cross-functional teams.
- 8Provide phase-appropriate strategic guidance for clinical and marketing applications.
- 9Oversee QA budget allocation to ensure timely, on-budget project completion.
- 10Coordinate with clients, consultants, and CROs for effective health authority interactions.
Requirements10
- 110+ years in compliance, quality, and CDMO/CMO management, focusing on regulatory documentation and lifecycle management.
- 210+ years of GMP/QA experience in biopharma.
- 3Knowledge of aseptic manufacturing processes.
- 4Broad knowledge of FDA and international regulations for GMPs and biopharma.
- 5Experience working independently with minimal oversight, managing multiple tasks and deadlines.
- 6Excellent verbal and written communication skills.
- 7Expert knowledge of full drug development process and ICH requirements.
- 8Experience with drug substances and products is desired.
- 9Strong strategic, analytical, and negotiation skills.
- 10Ability to influence cross-functional teams and motivate others toward company objectives.
Salary Insight
$85 - $95k per year
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