Director of Regulatory Affairs

Salary: $225k to $255k with a 20% Bonus.

Location: They would love someone that can be onsite 1 or 2 days a week or a couple times a month. Only East Coasters. NC to Boston. Additional Information and Challenges They are receiving candidates that do not have enough experience or they are Reg Ops and Reg/CMC and this experiences will not work. Biologics is a big plus and someone that has Global experience. No Direct Reports. Client is 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide. Our strategy is to develop medicines that target the IL-1? pathway, which is a central driver of the inflammatory process.

Position Summary: Client is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory support, the company’s lead asset, as it advances into Phase 3, and potential registration The Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. The ideal candidate will bring a balanced mix of strategic and operational regulatory expertise.

Essential Duties and Responsibilities: Design, lead, and implement global regulatory strategies to support the development, registration, and lifecycle management of assigned programs. Serve as the Regulatory Affairs representative on cross-functional project teams and provide proactive, strategic guidance to advance program objectives. Evaluate evolving regulatory requirements, competitive developments, and emerging scientific trends, and assess potential impacts on development strategy. Identify regulatory risks, develop mitigation plans, and communicate recommendations to project teams and senior leadership. Contribute to regulatory development plans supporting advancement throughout development to commercialization. Collaborate with senior regulatory leadership on major strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA planning, and labeling activities. Lead the planning, preparation, review, and submission of regulatory documents throughout the product lifecycle. Provide hands-on leadership for a broad range of U.S. and global regulatory submissions, such as DSURs, protocol amendments, information amendments, INDs, CTAs, labeling, etc. Ensure submissions are scientifically accurate, strategically aligned, compliant, and delivered on schedule. Lead and coordinate routine regulatory submissions independently while supporting more complex registration activities under the guidance of senior regulatory leadership. Support preparation and maintenance of future NDA/BLA and ex-U.S. marketing application activities. Serve as a key point of contact with FDA and support interactions with ex-U.S. regulatory agencies. Lead preparation of regulatory briefing materials, meeting requests, information packages, and responses to agency inquiries. Participate in and support regulatory authority meetings, teleconferences, and written communications. Coordinate regulatory intelligence and ensure project teams remain informed of evolving agency expectations. Manage external regulatory consultants and CRO partners supporting global CTA submissions, maintenance activities, and health authority responses. Drive accountability and alignment across functions to meet aggressive development timelines.

Additional Responsibilities: Participate in departmental initiatives, task forces, and special projects. Support diligence activities and regulatory assessments as needed. Perform other duties as assigned.

Required Education and Experience: Bachelor’s degree in scientific discipline required. Advanced degree (MS, PharmD, PhD, or equivalent) preferred.10–15 years of Regulatory Affairs experience within the biotechnology and/or pharmaceutical industry. Minimum of 5 years of experience within a small or emerging biotechnology company preferred. Demonstrated experience supporting late-stage clinical development programs. Experience supporting biologics development programs preferred. Proven experience authoring, reviewing, and managing a broad range of regulatory submissions, including INDs, CTAs, amendments, IND Safety Reports, DSURs, annual reports, and briefing packages. Experience interacting directly with FDA and supporting ex-U.S. regulatory activities. Experience managing CROs and external consultants supporting global regulatory submissions and agency responses. Experience supporting preparation for major regulatory milestones such as End-of-Phase 2 meetings, Phase 3 development programs, BLA preparation, and registration planning preferred. Knowledge, Skills &

Competencies: Deep understanding of global drug development and regulatory requirements for biologics. Strong knowledge of FDA regulations and familiarity with EMA and other international regulatory frameworks. Ability to thrive in a fast-paced biotechnology environment while managing multiple priorities and deadlines. Experience working in a cross-functional team Working in a fast-paced environment to ensure timelines are consistently met