Senior Regulatory Programs Strategist (Part-Time)

Gofractional; Alameda (CA); On-site; USD 117,000 - 131,000; Part time

Job summary

Gofractional is seeking a Senior Specialist, Regulatory Programs (Part-Time) in Alameda, CA. The role is on-site and focuses on planning, preparing, and managing regulatory submissions with clients, while leading QA and regulatory strategy across projects.

The successful candidate will bring 10+ years in GMP/QA and regulatory lifecycle management, with strong communication and cross-functional leadership to drive inspections, risk mitigations, and compliant product development.

Qualifications

• Bachelor's degree in a scientific discipline.
• At least 10 years in compliance, quality, and CDMO/CMO regulatory lifecycle.
• At least 10 years GMP/QA experience.
• Broad knowledge of FDA and international regulations related to GMPs and Biopharma.
• Experience with inspections by FDA and EMA.
• Strong communication and leadership across functions.

Responsibilities

• Plan, prepare, and manage submissions to health authorities including INDs and NDA/BLA filings with clients.
• Lead regulatory interactions and prepare briefing materials for HA meetings; oversee SMEs and follow-up.
• Negotiate with regulators and drive proactive regulator engagement.
• Communicate regulatory strategy, risks, and plans to management and cross-functional teams.
• Prepare regulatory registrations and licenses (FDA, state boards).
• Develop and implement a QA strategy aligned with regulatory requirements.
• Provide QA leadership to foster quality excellence and continuous improvement.
• Collaborate with cross-functional teams to embed QA in manufacturing processes.
• Foster a culture of quality and compliance across the organization.
• Offer phase-appropriate strategic guidance on regulatory requirements for trials and approvals.
• Collaborate with clients/CROs to ensure smooth HA interactions.
• Manage QA budget to ensure timely delivery within budget.

Skills

Regulatory expertise

Quality management

Project management

Communication skills

Cross-functional collaboration

Negotiation skills

Attention to detail

Independent work

Budget management

Education

Bachelor's degree in a scientific discipline

Job description

Gofractional is seeking a Senior Specialist, Regulatory Programs (Part-Time) in Alameda, CA. The role is on-site and focuses on planning, preparing, and managing regulatory submissions with clients, while leading QA and regulatory strategy across projects.

The successful candidate will bring 10+ years in GMP/QA and regulatory lifecycle management, with strong communication and cross-functional leadership to drive inspections, risk mitigations, and compliant product development.