Director of Regulatory Affairs
Viking Therapeutics, Inc.
August 25, 2026
On-site
San Diego Metropolitan Area
$190,000 - $210,000 USD yearly
Corporate Functions
Essential Duties and Responsibilities:
- Coordinate and execute planning, content development, and delivery of global regulatory submissions (especially NDA filing) and lifecycle management; ensure submissions are high quality and on-time.
- Perform detailed review and quality control of submission documents for scientific accuracy, internal consistency, regulatory compliance, and correct cross-references/citations.
- Manage component handoffs and publishing timelines; resolve hyperlinking/bookmarking/PDF/validation issues; confirm sequence numbering and lifecycle operators; verify FDA Electronic Submissions Gateway transmission/receipt.
- Maintain regulatory records, submission archives, correspondence logs, and tracking of regulatory commitments/agreements.
- Represent Regulatory on cross-functional teams; guide teams on regulatory requirements and risks for IND/CTA/NDA/MAA/IMPD filings.
- Develop/review/file INDs, CTAs, NDAs, briefing documents, including DSURs, annual reports, CSRs, protocols, Investigator Brochures, iPSP/PIP, Module 2 summaries, amendments, and related documents.
- Support health authority interactions (meeting requests, questions, briefing packages, rehearsals); contribute in meetings with FDA and other agencies.
- Contribute to global regulatory strategy for CMC, nonclinical, and clinical activities.
- Support product labeling development (USPI/patient labeling) and labeling review/negotiation.
- Conduct regulatory research and precedent analysis; communicate recommendations.
- Identify and escalate regulatory risks/issues with analyses, options, and mitigations.
- Support inspection readiness (PAI and BIMO) with CROs/CMOs.
- Supervise vendors/contractors: define scope, track spend vs. budget, review deliverables, and ensure quality/timeliness.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in a scientific discipline required; MS/PhD/PharmD preferred.
- 8+ years pharma/biotech experience with 6+ years Regulatory Affairs (advanced degree may substitute).
- Hands-on preparation, authoring, and reviewing of regulatory submission content; comfortable at document level.
- Experience contributing to at least one NDA/BLA/MAA (approval-cycle support preferred).
- Experience preparing briefing packages and supporting formal health authority meetings.
- Knowledge in IND/NDA and amendments/supplements; hands-on eCTD experience.
- FDA electronic submissions experience (eCTD validation criteria, PDF/hyperlink specs, lifecycle operators, gateway transmission).
- Working knowledge of GMP/GLP/GCP and pharma product lifecycle.
- Knowledge of FDA/ICH guidance; 21 CFR 312/314, ICH E6/M4 (CTD), PDUFA review procedures/goal dates.
Knowledge and Skills (Required/Preferred):
- Proficiency with Microsoft Office (advanced Word skills preferred).
- Proficiency with regulatory/document management & electronic publishing systems (e.g., Veeva Vault RIM, Lorenz docuBridge).
- High attention to detail; proofreading/editing; audit-ready citation verification.
- Preferred: drug-device combination product experience (21 CFR Part 4), metabolic/endocrine/cardiometabolic or peptide therapeutics experience, RAC certification.
- Strong analytical/problem-solving and communication skills; able to work independently and on-site at San Diego, CA headquarters.
- Coordinate and execute planning, content development, and delivery of global regulatory submissions (especially NDA filing) and lifecycle management; ensure submissions are high quality and on-time.
- Perform detailed review and quality control of submission documents for scientific accuracy, internal consistency, regulatory compliance, and correct cross-references/citations.
- Manage component handoffs and publishing timelines; resolve hyperlinking/bookmarking/PDF/validation issues; confirm sequence numbering and lifecycle operators; verify FDA Electronic Submissions Gateway transmission/receipt.
- Maintain regulatory records, submission archives, correspondence logs, and tracking of regulatory commitments/agreements.
- Represent Regulatory on cross-functional teams; guide teams on regulatory requirements and risks for IND/CTA/NDA/MAA/IMPD filings.
- Develop/review/file INDs, CTAs, NDAs, briefing documents, including DSURs, annual reports, CSRs, protocols, Investigator Brochures, iPSP/PIP, Module 2 summaries, amendments, and related documents.
- Support health authority interactions (meeting requests, questions, briefing packages, rehearsals); contribute in meetings with FDA and other agencies.
- Contribute to global regulatory strategy for CMC, nonclinical, and clinical activities.
- Support product labeling development (USPI/patient labeling) and labeling review/negotiation.
- Conduct regulatory research and precedent analysis; communicate recommendations.
- Identify and escalate regulatory risks/issues with analyses, options, and mitigations.
- Support inspection readiness (PAI and BIMO) with CROs/CMOs.
- Supervise vendors/contractors: define scope, track spend vs. budget, review deliverables, and ensure quality/timeliness.
- Other duties as assigned.
Requirements:
- Bachelor’s degree in a scientific discipline required; MS/PhD/PharmD preferred.
- 8+ years pharma/biotech experience with 6+ years Regulatory Affairs (advanced degree may substitute).
- Hands-on preparation, authoring, and reviewing of regulatory submission content; comfortable at document level.
- Experience contributing to at least one NDA/BLA/MAA (approval-cycle support preferred).
- Experience preparing briefing packages and supporting formal health authority meetings.
- Knowledge in IND/NDA and amendments/supplements; hands-on eCTD experience.
- FDA electronic submissions experience (eCTD validation criteria, PDF/hyperlink specs, lifecycle operators, gateway transmission).
- Working knowledge of GMP/GLP/GCP and pharma product lifecycle.
- Knowledge of FDA/ICH guidance; 21 CFR 312/314, ICH E6/M4 (CTD), PDUFA review procedures/goal dates.
Knowledge and Skills (Required/Preferred):
- Proficiency with Microsoft Office (advanced Word skills preferred).
- Proficiency with regulatory/document management & electronic publishing systems (e.g., Veeva Vault RIM, Lorenz docuBridge).
- High attention to detail; proofreading/editing; audit-ready citation verification.
- Preferred: drug-device combination product experience (21 CFR Part 4), metabolic/endocrine/cardiometabolic or peptide therapeutics experience, RAC certification.
- Strong analytical/problem-solving and communication skills; able to work independently and on-site at San Diego, CA headquarters.