Head of Regulatory Affairs

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

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.

• 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.

• 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.

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

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

• 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.

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

• 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.