Director of Regulatory Affairs

Director of Regulatory Affairs (Direct Hire)

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