Director, Regulatory Affairs
Viking Therapeutics, Inc.
August 25, 2026
On-site
San Diego, CA
Corporate Functions
Responsibilities:
- Manage/evaluate/execute regulatory projects and contribute to global regulatory strategy; directly support drafting and filing of an NDA.
- Coordinate global regulatory submission planning, content development, delivery, and lifecycle management (especially upcoming NDA) to ensure on-time, high-quality submission.
- Perform detailed QC of submission documents (accuracy, consistency, compliance, citations/cross-references) prior to publishing.
- Manage eCTD/component handoffs and publishing timelines; resolve hyperlinking/bookmarking/PDF specs/validation findings; confirm sequencing/lifecycle operators; verify FDA Gateway transmission/receipt.
- Maintain regulatory records, submission archives, correspondence logs, and track regulatory commitments/agreements.
- Represent Regulatory on cross-functional teams; advise on regulatory requirements and risks for IND/CTA/NDA/MAA/IMPD.
- Develop/review/file INDs/CTAs/NDAs and associated briefing documents (DSURs, annual reports, CSRs, protocols, investigator brochures, iPSP/PIP, Module 2 summaries, amendments/supplements).
- Support health authority interactions (meeting requests, questions, briefing packages, rehearsals; contribute in FDA/agency meetings).
- Conduct regulatory research and precedent analysis; identify/escalate regulatory risks with options/mitigations.
- Support inspection readiness (PAI/BIMO) across Company and contracted CROs/CMOs.
- Supervise contractors/vendors (define scope, track spend, review deliverables, ensure quality/timeliness).
Requirements:
- BS in scientific discipline required; MS/PhD/PharmD preferred.
- 8+ years pharma/biotech industry; 6+ years Regulatory Affairs (advanced degree may substitute).
- Hands-on experience authoring/reviewing submission content; comfortable working document-level.
- Experience contributing to at least one NDA/BLA/MAA (approval-cycle support preferred).
- Briefing package and health authority meeting support (Type A/B/C/D).
- Hands-on IND/NDA and amendment/supplement experience including eCTD.
- FDA electronic submissions experience (eCTD validation, PDF/hyperlink specs, lifecycle operators, gateway transmission).
- Knowledge of GMP/GLP/GCP and pharma product lifecycle; FDA/ICH guidance and 21 CFR 312/314; ICH E6 & M4 (CTD).
- Strong proficiency in Microsoft Office and Word; regulatory/IRM/RIM and e-publishing systems; attention to detail.
- Ability to work independently; prioritize concurrent deadlines; communicate clearly.
Preferred:
- Lean/virtual sponsor experience via external CROs/CMOs/consultants.
- Metabolic/endocrine/cardiometabolic or peptide therapeutic experience.
- RAC certification.
- Drug-device combination experience (21 CFR Part 4).
- On-site work at San Diego, CA headquarters.
Salary: $190,000–$210,000 annual salary.
- Manage/evaluate/execute regulatory projects and contribute to global regulatory strategy; directly support drafting and filing of an NDA.
- Coordinate global regulatory submission planning, content development, delivery, and lifecycle management (especially upcoming NDA) to ensure on-time, high-quality submission.
- Perform detailed QC of submission documents (accuracy, consistency, compliance, citations/cross-references) prior to publishing.
- Manage eCTD/component handoffs and publishing timelines; resolve hyperlinking/bookmarking/PDF specs/validation findings; confirm sequencing/lifecycle operators; verify FDA Gateway transmission/receipt.
- Maintain regulatory records, submission archives, correspondence logs, and track regulatory commitments/agreements.
- Represent Regulatory on cross-functional teams; advise on regulatory requirements and risks for IND/CTA/NDA/MAA/IMPD.
- Develop/review/file INDs/CTAs/NDAs and associated briefing documents (DSURs, annual reports, CSRs, protocols, investigator brochures, iPSP/PIP, Module 2 summaries, amendments/supplements).
- Support health authority interactions (meeting requests, questions, briefing packages, rehearsals; contribute in FDA/agency meetings).
- Conduct regulatory research and precedent analysis; identify/escalate regulatory risks with options/mitigations.
- Support inspection readiness (PAI/BIMO) across Company and contracted CROs/CMOs.
- Supervise contractors/vendors (define scope, track spend, review deliverables, ensure quality/timeliness).
Requirements:
- BS in scientific discipline required; MS/PhD/PharmD preferred.
- 8+ years pharma/biotech industry; 6+ years Regulatory Affairs (advanced degree may substitute).
- Hands-on experience authoring/reviewing submission content; comfortable working document-level.
- Experience contributing to at least one NDA/BLA/MAA (approval-cycle support preferred).
- Briefing package and health authority meeting support (Type A/B/C/D).
- Hands-on IND/NDA and amendment/supplement experience including eCTD.
- FDA electronic submissions experience (eCTD validation, PDF/hyperlink specs, lifecycle operators, gateway transmission).
- Knowledge of GMP/GLP/GCP and pharma product lifecycle; FDA/ICH guidance and 21 CFR 312/314; ICH E6 & M4 (CTD).
- Strong proficiency in Microsoft Office and Word; regulatory/IRM/RIM and e-publishing systems; attention to detail.
- Ability to work independently; prioritize concurrent deadlines; communicate clearly.
Preferred:
- Lean/virtual sponsor experience via external CROs/CMOs/consultants.
- Metabolic/endocrine/cardiometabolic or peptide therapeutic experience.
- RAC certification.
- Drug-device combination experience (21 CFR Part 4).
- On-site work at San Diego, CA headquarters.
Salary: $190,000–$210,000 annual salary.