Associate Director Regulatory Affairs

About Kolon TissueGene, Inc.

Kolon TissueGene, Inc. (KTG) is a clinical-stage biopharmaceutical company pioneering cell and gene therapy solutions to transform the treatment of patients with osteoarthritis and other serious conditions. Headquartered in Rockville, Maryland, we operate at the forefront of regenerative medicine, advancing a pipeline of innovative biologics through rigorous clinical development. As we prepare for a pivotal U.S. launch, we are building a mission-driven team to shape the future of biotech — and improve the quality of life for patients worldwide. As Associate Director, Regulatory Affairs, you will play a central role in shaping the regulatory strategy that brings these therapies to patients — working closely with senior leadership and cross-functional teams to navigate the FDA and global regulatory landscape.

Position Summary

The Associate Director, Regulatory Affairs supports the full spectrum of regulatory activities for KTG's biopharmaceutical product development programs across multiple stages of development. Reporting to the Vice President, Clinical and Regulatory Affairs, this role is responsible for preparing and managing regulatory submissions, serving as a key liaison with the FDA and other regulatory authorities, and providing strategic regulatory input across clinical, nonclinical, and manufacturing functions. A critical measure of success is the ability to meet regulatory timelines and key milestones — including FDA meetings and marketing application submissions — while maintaining the highest standards of quality and compliance.

Essential Job Functions & Duties

Core Responsibilities

• Prepare and submit regulatory filings to the FDA and other regulatory authorities, in consultation and collaboration with the VP of Clinical and Regulatory Affairs.
• Serve as liaison for all communications with the FDA and other regulatory authorities, as assigned.
• Ensure regulatory projects are properly resourced, managed, and executed within established timelines and quality standards for the assigned portfolio.
• Assist with review of clinical, nonclinical, and manufacturing documentation — including protocols, protocol amendments, case report forms, informed consent forms, safety reports, Investigator's Brochures, nonclinical study reports, batch records, and change requests — for regulatory compliance.
• Develop, update, and maintain departmental SOPs in collaboration with Quality Assurance to ensure compliance with applicable quality and regulatory requirements.
• Monitor changes in applicable regulations and guidelines; assess and communicate the impact of regulatory developments on product development programs.
• Provide strategic regulatory input across product development activities.
• Participate as a team member for FDA, Supplier, and Vendor audits.

General Responsibilities

• Support preparation of the Regulatory timeline and budget for assigned portfolio.
• Mentor and support junior Regulatory Affairs staff, as needed.
• Ensure proper maintenance of regulatory files (electronic and paper) and maintain the regulatory submissions and communications log.
• Provide regulatory advice and feedback on clinical, nonclinical, and manufacturing matters.

Required Qualifications

• Bachelor's degree (B.S.) in a biological or physical science discipline, or equivalent combination of education and experience; M.S. preferred.
• Minimum 8 years of experience in the biopharmaceutical industry, with at least 5 years of direct Regulatory Affairs experience including multiple FDA agency interactions.
• Demonstrated experience in the development of Biologics and preparing regulatory submissions for Biologics.
• Solid understanding of the drug development process, with emphasis on regulatory requirements.
• Excellent working knowledge of ICH and FDA guidelines and regulations.
• Strong organizational, managerial, and negotiation skills.
• Excellent verbal and written communication skills.
• Commitment to quality across all work tasks and deliverables.

Preferred Qualifications

• Advanced degree (M.S. or Ph.D.) in a relevant scientific discipline.
• Experience with gene therapy, cell therapy, or other advanced biologic modalities.
• Familiarity with global regulatory submissions beyond FDA (e.g., EMA, PMDA).
• Prior experience mentoring or managing regulatory staff.

Key Competencies

• Regulatory strategy and submission management across multiple development stages.
• Clear, precise written and verbal communication with internal teams, external partners, and regulatory agencies.
• Structured project management with ability to manage competing priorities and tight timelines.
• Cross-functional collaboration and stakeholder engagement across clinical, nonclinical, and manufacturing teams.
• Analytical rigor and attention to detail in reviewing complex scientific and regulatory documentation.
• Adaptability and sound judgment in a fast-paced, evolving regulatory environment.

Work Environment & Conditions

• Full-time, onsite office-based (M-F) at KTG headquarters in Rockville, MD.
• Standard business hours, Monday–Friday; occasional evening hours may be required for telephone or videoconferences with global partners.
• Up to approximately 10% local/regional travel may be required.

Physical Requirements

• Ability to sit for extended periods at a computer workstation.
• Extensive keyboarding involving repetitive finger motion.
• Ability to communicate via telephone and video conference.
• Ability to lift, push, or carry up to 25 lbs occasionally.

Compensation & Benefits

Salary Range: $145,000 – $175,000 per year (commensurate with experience)

Benefits Highlights:

• Onsite yet flexible work schedules
• Premium-free global health insurance (50% dependent coverage)
• 401(k) with immediate eligibility
• Long-term incentive bonuses
• On-site gym & wellness perks
• Extra PTO accrual every year
• Global and local training opportunities

Equal Employment Opportunity

Kolon TissueGene, Inc. is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

Disability & Veteran Self-Identification

We invite all applicants to voluntarily self-identify as a person with a disability and/or a protected veteran. This information is collected for compliance with federal regulations and will not affect hiring decisions. Submission is voluntary and confidential.

If you require a reasonable accommodation to participate in the application or interview process—such as completing an application, submitting materials, or attending an interview—please contact us at hr@tissuegene.com. All requests for accommodation will be handled confidentially and in accordance with applicable laws.