Kelly Science, Engineering, Technology & Telecom · 14 hours ago
Regulatory Affairs Lead
United States
Part-time
Remote
Senior Level
$80/hr - $85/hr
5+ years expKelly Science, Engineering, Technology & Telecom is seeking a seasoned Regulatory Affairs Lead to support a clinical-stage gene therapy program entering a Phase I clinical trial. The role focuses on providing regulatory leadership and execution support during the transition from an Investigator-Initiated Trial to a Sponsor-Initiated Trial.
Staffing & Recruiting
Hiring Manager
Tanya Hendrick, MBA, MS
Responsibilities
Sponsorship Transition: Lead the strategic hand-off of regulatory functions from the clinical partner (Clinic) to our client, ensuring no gaps in compliance or communication
IND Lifecycle Support: Drive the preparation, submission, and maintenance of IND applications and amendments for a gene therapy program
FDA Liaison: Act as the primary point of contact for all communications with regulatory bodies, managing formal responses and meeting preparations
Clinical Strategy: Provide regulatory oversight for a Phase I study (currently 9 patients), ensuring the project objectives align with FDA expectations for safety and efficacy
Compliance & Timelines: Establish and manage the regulatory roadmap, ensuring all filings, annual reports, and safety updates meet strict federal deadlines
Qualification
Required
Advanced degree (MS, PhD, PharmD, or JD) in a scientific or legal discipline
Minimum 5+ years of experience in Regulatory Affairs with a proven track record of successful IND/CTA submissions
Direct experience with Gene Therapy, Cell Therapy, or complex Biologics is mandatory
Hands-on experience managing 'Investigator to Sponsor' transitions and handling FDA formal responses
Understanding of the manufacturing requirements for gene therapies, as these are often the most scrutinized parts of the IND
Proven track record working with advanced biologics or gene therapy products
Understanding of the shift from Investigator-initiated studies to Sponsor-initiated trials and experience regarding clinical trial sponsor regulatory expectations
Direct experience with the IND submission process, FDA negotiations, and Phase I clinical trial regulations
Sufficient experience to work independently in a remote capacity, providing high-level strategy without needing daily supervision
Ability to translate complex regulatory requirements into actionable project timelines for the executive team
Preferred
Experience with Orphan Drug Designation (ODD) and Fast Track/Breakthrough Therapy applications
Previous experience in a 'Virtual' or small biotech environment where a 'hands-on' approach to filing is required
RAC (Regulatory Affairs Certification) is a plus
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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