Director of Regulatory Affairs

Manage, evaluate, and execute regulatory projects aligned with company goals, contributing to global regulatory strategy. Directly support the drafting and filing of an NDA, maintain electronic regulatory files, review and oversee production of CMC, nonclinical, clinical, and regulatory documents, and represent Regulatory in cross-functional teams. Oversee day-to-day activities of external publishing and consulting vendors.

Responsibilities

• Coordinate and execute planning, content development, and delivery of global regulatory submissions (especially the upcoming NDA filing) and life cycle management, ensuring submissions are high-quality, on-time, and aligned with company goals.
• Perform detailed review and quality control of submission documents and components prior to release for publishing, assessing scientific accuracy, internal consistency, 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 on regulatory requirements and risks to support clinical development programs, including preparation and maintenance of INDs, CTAs, NDAs, MAAs, and IMPD filings.
• Develop, review, and/or file INDs, CTAs, NDAs, briefing documents, 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 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 and strategize on new/emerging regulations and development issues, and communicate recommendations to management and project teams. Perform precedent analysis using publicly available regulatory records.
• Identify and escalate regulatory risks and issues to the Vice President of Regulatory Affairs with supporting analysis, available options, and proposed mitigations.
• 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, and hold partners accountable for quality and timeliness.
• Other duties as assigned.

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. Comfortable working at the document level without reliance on others for production or quality-checking.
• 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, including hands-on experience with eCTD, amendments, and supplements (manufacturing, nonclinical, clinical).
• 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 the pharmaceutical product life cycle.
• Working knowledge of FDA and ICH regulatory guidance and regulations, including 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.

Skills

• High degree of proficiency in Microsoft Office Suite (Word, PowerPoint, etc.), Outlook, WebEx, and 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 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 interfaces with human factors engineering and design control, is preferred.
• Strong analytical, interpersonal, and problem-solving skills with the ability to work collaboratively.
• Ability to contribute substantively to regulatory strategy discussions and 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.
• Excellent written and verbal communication skills.

Pay

$190,000.00 - $210,000.00 annual salary.

Schedule

On-site at the Company's San Diego, California headquarters.