Regulatory Specialist - Intellectt INC

Regulatory Specialist - Remote
We are seeking an experienced Regulatory Specialist to support oncology clinical trials for our client. The ideal candidate will have a strong background in regulatory affairs, with specific expertise in IND studies, expanded access programs, and FDA filings.

Key Responsibilities:

• Prepare and submit regulatory documents for Investigational New Drug (IND) applications, including initial submissions, amendments, and annual reports
• Manage expanded access requests and compassionate use programs, including individual patient INDs and treatment protocols
• Coordinate and prepare regulatory submissions for FDA meetings (e.g., pre-IND, End-of-Phase 2, single-patient IND)
• Ensure compliance with FDA regulations and applicable industry guidance, ICH guidelines, and other applicable regulatory requirements
• Collaborate with the sponsor's medical officer and trial manager to prepare and submit Safety Reports, including expedited safety reports and periodic safety updates
• Manage and track regulatory timelines and commitments
• Serve as a liaison between the company and regulatory authorities
• Stay current with evolving regulatory requirements and guidelines in oncology drug development
• Other duties as assigned by trial manager, sponsor's medical officer or senior management

Qualifications:

• Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred
• 5+ years of experience in regulatory affairs, with a focus on oncology IND studies
• Demonstrated experience in preparing and submitting IND applications and related documents to the FDA
• In-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements
• Experience managing expanded access requests and compassionate use programs
• Familiarity with electronic submission systems (e.g., eCTD, CDER Direct)
• Strong understanding of the drug development process and clinical trial design
• Excellent written and verbal communication skills
• Ability to interpret and apply complex regulatory guidelines

Preferred Qualifications:

• Experience with breakthrough therapy designation and accelerated approval pathways
• Experience with biologics license applications (BLAs)
• Regulatory Affairs Certification (RAC)

Key Competencies:

• Attention to detail and accuracy
• Strong analytical and problem-solving skills
• Ability to manage multiple projects and prioritize effectively
• Excellent organizational and time management skills
• Adaptability to changing regulatory landscapes
• Strong interpersonal skills and ability to work in cross-functional teams