Senior Specialist, Regulatory Programs (Part-Time)

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. Formed in 2023, GeneFab combines industry-leading expertise in synthetic biology with advanced cGMP capabilities to accelerate the development and commercialization of genetic medicines. The company offers an extensive technology platform and know-how spanning early-stage product design, technical development, and cGMP-compliant production. GeneFab's technology includes bioinformatic-guided discovery of cell-type promoters, directed evolution of small molecule-regulated gene switches, and engineering highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse workplace, believing that different perspectives lead to better ideas and a deeper understanding of the needs of our diverse team.

Responsibilities

• Plan, prepare, and manage submissions to health authorities (HAs), including INDs and NDA/BLA regulatory filings, in strong collaboration with GeneFab’s clients.
• Participate in regulatory interactions with HAs, including managing preparation of briefing materials for HA meetings, preparing subject matter experts (SMEs), and ensuring appropriate follow-up.
• Participate in negotiations with regulatory agencies to resolve and review issues, and shepherd proactive interactions with regulators.
• Effectively communicate the regulatory strategy, risks, mitigations, and overall plans to Regulatory Affairs, program teams, and senior management.
• Prepare and manage GeneFab’s regulatory registrations and/or licenses (e.g., FDA, Oregon Board of Pharmacy).
• Develop and implement a comprehensive quality assurance strategy aligned with the organization's goals and regulatory requirements.
• Provide strategic direction and leadership to the Quality Assurance team, fostering a culture of quality excellence and continuous improvement.
• Collaborate with cross-functional teams to integrate quality principles into all aspects of the pharmaceutical manufacturing process.
• Foster a culture of quality and compliance by promoting awareness and understanding of quality principles throughout the organization.
• Independently provide effective phase-appropriate strategic guidance related to current regulatory requirements and expectations for clinical trial applications and marketing applications.
• Work in close collaboration with clients, consultants, and/or CROs to ensure appropriate interactions with HAs.
• Manage the QA budget to ensure resources are allocated appropriately and projects are completed on time and within budget.
• All other duties as assigned.

Requirements

• Minimum of a bachelor’s degree, preferably in a scientific discipline.
• 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.
• Knowledge of GMP requirements and quality regulations within the Biopharma industry, backed by extensive experience preparing for and successfully navigating inspections by global regulatory agencies, including the FDA and EMA.
• Experience with drug substances and drug products is desired.
• Knowledge of regulatory requirements across development stages and post-approval is essential.
• Expert working knowledge of the 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 influence multiple functions and motivate others to accomplish company objectives.
• Self-motivated and detail-oriented with sound judgment and innovative thinking to address challenges and opportunities.

Skills

• Regulatory strategy development and execution for complex products.
• Preparation and management of regulatory submissions (INDs, NDAs, BLAs).
• Leadership and management of Quality Assurance teams.
• Cross-functional collaboration to integrate quality principles into manufacturing processes.
• Budget management for QA initiatives.
• Stakeholder communication and negotiation with regulatory agencies.