Director, Global Regulatory Strategy & NDA Submissions

Viking Therapeutics; San Diego (CA); On-site; USD 190,000 - 210,000; Full time

Job summary

Viking Therapeutics, Inc., in San Diego, California, seeks a Director of Regulatory Affairs to lead regulatory projects, develop global strategies, and coordinate NDA filings. The role includes managing regulatory documents, liaising with cross-functional teams, and supervising external publishing vendors.

The RA Director will contribute to IND/NDAs, maintain submission content plans, and ensure compliance with FDA expectations, ICH guidelines, and GMP/GCP standards in a lean, virtual sponsor

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Advanced degree preferred (MS/PhD/PharmD).
• Experience with NDA/BLA/MAA submissions is a plus.

Responsibilities

• Coordinate global regulatory submissions and NDA filings on time.
• Review and quality control submission documents and references.
• Manage publishing timelines and vendor coordination.
• Maintain regulatory records and health authority logs.
• Represent Regulatory in cross-functional teams.
• Develop and file INDs, NDAs, CSRs, and related documents.
• Support health authority interactions and meetings.
• Contribute to global regulatory strategies across programs.
• Assist labeling development and USPI review.
• Assess new regulations and advise management.
• Escalate regulatory risks to VP of Regulatory Affairs.
• Support inspections readiness and CRO/CMO coordination.
• Oversee contractors and vendors; ensure quality and timeliness.
• Other duties as assigned.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Attention to detail

Project management

Communication skills

Independent working

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PhD, PharmD, or equivalent) preferred

Tools

Veeva Vault RIM

Lorenz docuBridge

Microsoft Office Suite

Job description

Viking Therapeutics, Inc., in San Diego, California, seeks a Director of Regulatory Affairs to lead regulatory projects, develop global strategies, and coordinate NDA filings. The role includes managing regulatory documents, liaising with cross-functional teams, and supervising external publishing vendors.

The RA Director will contribute to IND/NDAs, maintain submission content plans, and ensure compliance with FDA expectations, ICH guidelines, and GMP/GCP standards in a lean, virtual sponsor