Director, Regulatory Affairs

Viking Therapeutics, Inc.•San Diego, CA

10d•$190,000 - $210,000•Onsite

About The Position

The Director of Regulatory Affairs (RA Director) will manage, evaluate, and execute regulatory projects consistent with company goals, and will contribute to the development of global regulatory strategy. This position will directly support the drafting and filing of a NDA. The RA Director is responsible for maintaining electronic regulatory files, reviewing, and overseeing the production of CMC, nonclinical, clinical and regulatory documents in support of investigational and marketing applications, representing Regulatory in cross-functional teams, and directing the day-to-day activities of the external publishing and consulting vendors that support the function. The Vice President of Regulatory Affairs retains overall accountability for program-level regulatory strategy. Within that framework, the RA Director is expected to contribute substantively to strategy discussions and then to execute the resulting work directly — including detailed review and quality control of submission documents, maintenance of submission content plans and regulatory records, and hands-on coordination of the outsourced publishing vendor. This is a working role within a lean, virtual-sponsor operating model.

Requirements

Bachelor's degree in a scientific discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred.
Minimum of 8 years of pharmaceutical or biotechnology industry experience, including at least 6 years in Regulatory Affairs. An advanced degree may substitute for up to two years of experience (6+ years industry / 4+ years Regulatory Affairs).
Current, hands-on experience preparing, authoring, and reviewing regulatory submission content. The successful candidate will be comfortable working at the document level and will not depend on others to produce or quality-check deliverables.
Demonstrated experience contributing to at least one NDA, BLA, or MAA; experience supporting an application through an approval cycle is preferred.
Experience preparing briefing packages and supporting formal health authority meetings (e.g., Type A, Type B, Type C, and Type D).
Experience and knowledge in preparation of INDs and NDAs, and supportive amendments and supplements (manufacturing, nonclinical, clinical) including hands-on experience with eCTD.
Demonstrated experience with electronic submissions to FDA, including working familiarity with eCTD validation criteria, PDF and hyperlinking specifications, submission lifecycle operators, and gateway transmission.
Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
Working knowledge of FDA and ICH regulatory guidance and regulations. Working knowledge of 21 CFR Parts 312 and 314, ICH E6 and M4 (CTD), and PDUFA review procedures and goal dates.
Experience at a small or mid-size sponsor operating through external CROs, CMOs, and consultants (lean or virtual operating model) is strongly preferred.
Experience in metabolic, endocrine, or cardiometabolic therapeutic areas, or with peptide therapeutics, is preferred.
Regulatory Affairs Certification (RAC) is a plus.
High degree of proficiency in the Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom. Advanced Word skills, including styles, tracked changes, cross-references, and template management.
Working proficiency with regulatory information management, document management, and electronic publishing systems (e.g., Veeva Vault RIM, Lorenz docuBridge, or comparable), and with secure agency correspondence methods.
High attention to detail and excellent proofreading and editing skills. Ability to verify citations to guidance, regulation, and precedent to an audit-ready standard.
Drug-device combination product experience under 21 CFR Part 4, including autoinjector or pen presentations and the interfaces with human factors engineering and design control, is preferred.
Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion.
Ability to contribute substantively to regulatory strategy discussions and to articulate a supported position clearly and concisely to management.
Willingness to move fluidly between strategic discussion and detailed execution.
Ability to work independently with minimal supervision, prioritize across concurrent programs and competing deadlines, and drive work to completion in a fast-paced, resource-constrained environment.
Team player with excellent written and verbal communication skills.
Ability to work on-site at the Company's San Diego, California headquarters.

Nice To Haves

Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
Experience supporting an application through an approval cycle is preferred.
Experience at a small or mid-size sponsor operating through external CROs, CMOs, and consultants (lean or virtual operating model) is strongly preferred.
Experience in metabolic, endocrine, or cardiometabolic therapeutic areas, or with peptide therapeutics, is preferred.
Regulatory Affairs Certification (RAC) is a plus.
Drug-device combination product experience under 21 CFR Part 4, including autoinjector or pen presentations and the interfaces with human factors engineering and design control, is preferred.

Responsibilities

Coordinate and execute the planning, content development, and delivery of global regulatory submissions (especially the upcoming NDA filing) and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time.
Perform detailed review and quality control of submission documents and components prior to release for publishing, assessing scientific accuracy, internal consistency across documents, regulatory compliance, and correctness of cross-references and citations.
Manage component handoffs and publishing timelines, review draft published output, resolve hyperlinking, bookmarking, PDF specification, and validation findings, confirm sequence numbering and lifecycle operators, and verify successful transmission and receipt through the FDA Electronic Submissions Gateway.
Maintain regulatory records, submission archives, health authority correspondence logs, and tracking of regulatory commitments and agreements.
Represent Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, NDA, MAA, and IMPD filings.
Develop, review and/or file INDs, CTAs, NDAs, briefing documents including authoring, reviewing, and/or managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, pediatric study plans (iPSP/PIP), Module 2 summaries, amendments, and other documents as needed.
Support preparation for health authority interactions, including meeting requests, question development, briefing package assembly and authoring, and rehearsal logistics; participate in meetings with FDA and other agencies as a functional contributor.
Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
Contribute to the development of product labeling, including USPI and associated patient labeling, and support labeling review and negotiation activities.
Conduct regulatory research, analyze, strategize, and communicate recommendations regarding new/emerging regulations and development issues as they arise to management and project teams as needed. Perform precedent analysis using publicly available regulatory records (e.g., approval packages, review memoranda, advisory committee materials, and approved labeling).
Identify and escalate regulatory risks and issues to the Vice President of Regulatory Affairs with supporting analysis, available options, and proposed mitigations, distinguishing clearly between what guidance and precedent support and what remains unsettled.
Support inspection readiness activities, including pre-approval inspection (PAI) and BIMO preparation across the Company and its contracted CROs and CMOs.
Collaborate with and supervise contributions from contractors and vendors. Define scope of work, track spend against budget, review deliverables on receipt, and hold medical writing, publishing, and regulatory consulting partners accountable for quality and timeliness.
Other duties as assigned.