Regulatory Strategy Director - NDA & Global Submissions

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

Job summary

Viking Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy and manage regulatory submissions, including NDA filings.

You will oversee the preparation of CMC, nonclinical, and clinical documents, coordinate with cross-functional teams, and supervise external vendors in a lean, virtual operating model. The role requires directing submission content plans, maintaining regulatory records, and engaging with FDA and other agencies.

Qualifications

• Bachelor's degree in a scientific discipline required.
• Minimum of 8 years of pharmaceutical/biotech industry experience, including at least 6 years in Regulatory Affairs.
• Experience preparing, authoring, and reviewing regulatory submission content, including INDs/NDAs/MAA.
• Demonstrated experience contributing to at least one NDA, BLA, or MAA; experience supporting an approval cycle is preferred.
• Experience with eCTD and FDA submissions; knowledge of 21 CFR Parts 312/314 and ICH guidelines.

Responsibilities

• Coordinate and execute planning, content development, and delivery of global regulatory submissions (NDA focus) and lifecycle management.
• Perform detailed review and QC of submission documents; ensure regulatory compliance and accurate cross references.
• Manage publishing timelines, vendor coordination, and FDA gateway transmission.
• Maintain regulatory records, submission archives, and health authority correspondence logs.
• Support regulatory strategy discussions and preparation of INDs/NDAs/CTAs and related documents.

Skills

Regulatory strategy

Regulatory submissions

eCTD knowledge

Cross-functional teamwork

Vendor management

FDA submissions

Compliance knowledge

Education

Bachelor's degree in science

Advanced degree (MS/PhD/PharmD)

Tools

Veeva Vault RIM

docuBridge

eCTD tools

Job description

Viking Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy and manage regulatory submissions, including NDA filings.

You will oversee the preparation of CMC, nonclinical, and clinical documents, coordinate with cross-functional teams, and supervise external vendors in a lean, virtual operating model. The role requires directing submission content plans, maintaining regulatory records, and engaging with FDA and other agencies.