Director, Global Regulatory Strategy & NDA Submissions

Viking Therapeutics; San Diego (CA); Presencial; USD 190 000 - 210 000; Tempo integral

Resumo da oferta

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

Qualificações

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

Responsabilidades

• 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.

Conhecimentos

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Attention to detail

Project management

Communication skills

Independent working

Formação académica

Bachelor's degree in a scientific discipline

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

Ferramentas

Veeva Vault RIM

Lorenz docuBridge

Microsoft Office Suite

Descrição da oferta de emprego

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