Director, Regulatory Affairs (3 FTE Roles)

Director, Regulatory Affairs Position Overview

The company is seeking a strategic and execution-focused Director, Regulatory Affairs, to provide global regulatory leadership for assigned development programs as they advance through late-stage clinical development and toward 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 product lifecycle management. The ideal candidate will bring a balanced combination of strategic regulatory expertise, hands‑on execution, and experience navigating the regulatory requirements of a dynamic biotechnology environment.

Essential Duties and Responsibilities

• Develop, 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, providing proactive regulatory guidance to support program objectives and development milestones.
• Evaluate evolving regulatory requirements, competitive developments, and emerging industry trends to assess potential impacts on development plans and regulatory strategy.
• Identify regulatory risks, develop mitigation strategies, and communicate recommendations to project teams and senior leadership.
• Contribute to integrated regulatory and development plans supporting progression from clinical development through commercialization.
• Collaborate with senior regulatory leadership on strategic initiatives, including FDA and global health authority meetings, registration strategy, BLA/NDA planning, and labeling activities.
• Lead the planning, preparation, review, and submission of regulatory documentation throughout the product lifecycle.
• Provide hands‑on leadership for U.S. And international regulatory submissions, including INDs, CTAs, protocol amendments, information amendments, DSURs, annual reports, and labeling documentation.
• Ensure regulatory submissions are accurate, compliant, strategically aligned, and delivered within established timelines.
• Independently manage routine regulatory submissions and maintenance activities while supporting complex registration‑related activities in collaboration with senior regulatory leadership.
• Support the preparation and maintenance of future NDA/BLA and ex‑U.S. Marketing authorization applications.
• Serve as a key regulatory contact for the FDA and support interactions with other international health authorities.
• Lead the preparation of regulatory briefing packages, meeting requests, information packages, and responses to health authority inquiries.
• Participate in and support regulatory authority meetings, teleconferences, and written communications.
• Monitor regulatory intelligence and communicate evolving agency expectations and regulatory precedents to relevant project teams.
• Manage external regulatory consultants and CRO partners supporting global CTA submissions, regulatory maintenance, and health authority responses.
• Drive cross‑functional accountability and alignment to meet critical development milestones and regulatory timelines.

Additional Responsibilities

• Participate in departmental initiatives, task forces, and special projects.
• Support due diligence activities, regulatory assessments, and related business initiatives as needed.
• Perform other duties as assigned.

Required Education and Experience

Bachelor's degree in a 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. Experience within a small or emerging biotechnology company preferred, including the ability to operate effectively in a resource‑conscious environment. Demonstrated experience supporting late‑stage clinical development programs. Experience supporting biologics development programs preferred. Proven experience authoring, reviewing, coordinating, and managing regulatory submissions, including INDs, CTAs, amendments, IND safety reports, DSURs, annual reports, and regulatory briefing packages. Experience interacting directly with the FDA and supporting regulatory activities in international markets. Experience managing CROs and external consultants supporting global regulatory submissions and health authority interactions. Experience supporting key regulatory milestones, including End‑of‑Phase 2 meetings, Phase 3 development planning, BLA preparation, and global registration strategy preferred.

Knowledge, Skills, and Competencies

Strong understanding of global drug development processes and regulatory requirements for biologics. Thorough knowledge of FDA regulations and familiarity with EMA and other international regulatory frameworks. Demonstrated ability to develop regulatory strategy while maintaining hands‑on responsibility for submission execution and regulatory operations. Strong written and verbal communication skills, including the ability to translate complex regulatory requirements into clear recommendations for cross‑functional teams and senior leadership. Proven ability to manage multiple priorities, anticipate regulatory challenges, and deliver high‑quality work within aggressive timelines. Ability to work effectively in a fast‑paced biotechnology environment with evolving priorities and limited resources. Strong cross‑functional collaboration, organizational, and project management skills. Demonstrated accountability and sound judgment in supporting development programs and regulatory decision‑making.

Travel

Less than 5% travel.

Equal Opportunity Employer

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

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