Director, Regulatory Affairs

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.

Essential Duties and Responsibilities

The Regulatory Affairs responsibilities of this role include but are not limited to the following:

• 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.