Senior Specialist, Regulatory Programs (Part-Time)
On-siteAlameda, California, United States
Job Summary
Plan, prepare, and manage submissions to Health Authorities including INDs, NDA/BLA filings, and prepare briefing materials for regulatory meetings. Negotiate with agencies to resolve issues and shepherd proactive interactions while developing and implementing a comprehensive quality assurance strategy aligned with cGMP capabilities. Provide strategic direction to the Quality Assurance team, foster a culture of quality excellence, and integrate quality principles into pharmaceutical manufacturing processes. Manage the QA budget to ensure resources are allocated appropriately and all projects are completed on time. This part-time role supports GeneFab's vision to accelerate the development and commercialization of genetic medicines through advanced synthetic biology and cGMP production.
Required Qualifications
- Minimum of a bachelor's degree, preferably in a scientific discipline.
- A minimum of 10 years of experience in compliance, quality, and CDMO/CMO management with a focus on regulatory documentation and lifecycle management.
- Minimum of 10 years of GMP/QA experience.
- General knowledge of aseptic manufacturing processes.
- Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
- Experience organizing and managing work responsibilities while working independently with minimal oversight.
- Time and project management skills with the ability to multi-task and meet deadlines.
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Broad knowledge of FDA and international regulations related to GMPs and BioPharma.
- Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience in preparing for and successfully navigating inspections conducted by global regulatory agencies, including the FDA and EMA authorities.
- Knowledge of regulatory requirements across development stages and post-approval is essential.
- Expert working knowledge of full drug development process and knowledge of FDA and ICH regulatory requirements.
- Strong strategic and analytical abilities, diplomacy, and negotiation skills.
- The ability to collaboratively influences multiple functions and motivates others to accomplish company objectives.
- Self-motivated and detail oriented with sound judgement and innovative thinking to deal with challenges/opportunities.
Desired Qualifications
- Experience with drug substances and drug products is desired.
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