Head of Regulatory Affairs

Senior Manager/ Head of Regulatory Affairs- Vaccines & Biologics (BLA Stage)

Position Summary

The Regulatory Affairs Director for Vaccines & Biologics (BLA Stage) is responsible for leading all regulatory activities related to late-stage development and licensure of vaccine and biologic products. This role focuses on BLA preparation, registration strategy, and ongoing coordination with global regulatory authorities and the SFDA.

Key Responsibilities Regulatory Strategy & Leadership

• Develop and drive global regulatory strategies tailored to programs.
• Define regulatory milestones, risk mitigation, and approval pathways.
• Advise senior leadership on regulatory expectations and strategy.
• Lead planning, authoring, and submission of BLA modules (1-5).
• Oversee global marketing applications such as MAA.
• Manage IND amendments, CTA submissions, and responses to regulatory review questions.

SFDA Regulatory Collaboration

• Act as the primary regulatory contact for SFDA.
• Manage pre-BLA consultations and technical meetings.
• Ensure compliance with SFDA requirements for clinical data, CMC data, inspections, and lot release documentation.
• Coordinate responses to SFDA inquiries and supplementary information requests.

Global Health Authority Interactions

• Communicate with FDA, EMA, MHRA, WHO, and other agencies.
• Prepare briefing materials and represent the company in regulatory meetings.

Cross-Functional Collaboration

• Work closely with CMC, clinical, QA/QC, and manufacturing teams.
• Provide regulatory guidance for validation strategies, analytical methods, and control strategies.

Compliance & Regulatory Intelligence

• Maintain expertise in FDA, EMA, ICH, SFDA, and WHO regulations.
• Ensure all activities meet global regulatory standards.
• Support development of internal SOPs and best practices.
• Mentor and lead regulatory affairs staff.
• Manage external consultants and dossier publishing partners.

Qualifications & Experience Education

• Advanced degree in life sciences, biotechnology, pharmacy, or related field (PhD, PharmD, or MSc preferred).

Professional Experience

• 8+ years of regulatory affairs experience in vaccines or biologics.
• Proven track record with BLA/MAA submissions.
• Experience with SFDA regulatory activities.
• Deep understanding of vaccine and biologic regulatory pathways.
• Strong CMC, clinical, and quality system knowledge.
• Excellent leadership, communication, and project management skills.

How to Apply