Associate Director Regulatory Affairs

Kaztronix LLC; Radnor (Delaware County); On-site; USD 180,000 - 250,000; Full time

Job summary

Kaztronix LLC is seeking a Director of Regulatory Affairs to provide global leadership across late-stage development, regulatory submissions, and health authority interactions. You will drive strategy, ensure timely submissions, and lead cross-functional teams in a resource-constrained biotech environment.

The role requires hands-on execution, strong communication, and a proven track record in INDs, CTAs, DSURs, and global registrations with FDA and international authorities.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• 10–15 years of Regulatory Affairs experience.
• Experience in biotechnology/pharmaceutical industry, including late-stage development.
• Experience authoring and coordinating submissions (INDs, CTAs, DSURs, annual reports).
• Experience with FDA interactions and global health authority activities.

Responsibilities

• Develop and lead global regulatory strategies for programs.
• Represent Regulatory Affairs on cross-functional teams.
• Evaluate regulatory requirements and industry trends.
• Identify regulatory risks and mitigation strategies.
• Support integrated regulatory and development plans.
• Collaborate on FDA meetings and global registration strategy.
• Lead preparation and submission of regulatory documents.
• Provide hands-on leadership for US and international submissions.
• Ensure submissions are accurate and timely.
• Manage CROs and external consultants.
• Drive cross-functional alignment to meet milestones.
• Support NDA/BLA planning and post-approval activities.
• Interact with FDA and other health authorities.
• Lead regulatory briefing packages and responses.
• Monitor regulatory intelligence for project teams.
• Support due diligence and departmental initiatives.

Skills

Regulatory strategy

Regulatory submissions

FDA interactions

Cross-functional leadership

Project management

Regulatory risk assessment

Communication

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Job description

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.
• 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.