Key Responsibilities
Regulatory Strategy & Execution
- Lead Global Strategy: Formulate innovative, accelerated CMC regulatory strategies for Client advanced therapy medicinal products (ATMPs), focusing on AAV-mediated gene therapies, antisense oligonucleotides (ASOs), and alternative CNS platforms.
- Lifecycle Filings: Lead the authoring, technical review, and global submission of high-quality CMC sections (Module 2 and Module 3) for INDs, IMPDs, CTAs, and future BLAs/MAAs.
- Agency Interactions: Direct or support formal interactions, briefing document preparation, and Type B/C meetings with the FDA, EMA, and other major health authorities on complex gene therapy manufacturing topics.
- Regulatory Intelligence: Track evolving global regulations impacting cell and gene therapies, including FDA tissue-specific guidance, GMO applications in Europe, and expedited designations (e.g., RMAT, PRIME).
Technical Operations & Quality Collaboration
- Matrix Leadership: Serve as the core regulatory CMC expert on cross-functional project teams, closely partnering with internal Quality Assurance, Process Development, and Analytical Development teams.
- CDMO Oversight: Provide regulatory guidance to external Contract Development and Manufacturing Organizations (CDMOs) regarding vector manufacturing, analytical comparability protocols, stability testing, and validation protocols.
- Risk Management: Conduct critical regulatory risk assessments for technical changes in manufacturing processes, scale-up protocols, or analytical method transfers, offering robust mitigation strategies.
Job Requirements & Qualifications
Experience Levels
- Senior Manager: 6 to 9+ years of experience in biotech/pharma Regulatory Affairs CMC or related technical roles.
- Associate Director: 10 to 12+ years of relevant experience, with a proven track record of leading regulatory submissions independently.
Technical & Scientific Profile
- Advanced Biologics Expertise: Deep, hands-on regulatory experience with advanced modalities. Direct experience with viral vectors (AAV, Lentivirus), cell/gene therapies, or complex biologics is strictly required .
- CNS Familiarity: Prior experience navigating the specific CMC challenges of CNS therapies (e.g., low volume/high potency fill-finish parameters, intrathecal delivery specifications) is highly preferred.
- Global Regulatory Proficiency: Comprehensive fluency with FDA, EMA, and ICH requirements regarding GMP, analytical validation, and eCTD structure.
- Agile Mindset: Thrives in a lean organizational structure backed by external networks; must possess excellent written communication skills and the autonomy to manage diverse external consultants.
Education
- Minimum Required: Bachelor s degree in molecular biology, biochemistry, chemical engineering, or a related life sciences discipline.
- Preferred: Advanced degree (Ph.D., PharmD, or MS) with focused research or industry experience in gene transfer technology.
Core Competencies & Culture Fit
- Mission Alignment: Passionate about bringing transformative therapeutics to patients with neurogenetic conditions and rare diseases.
- Agility & Ownership: Willing to move seamlessly between writing technical summaries and setting high-level strategic alignment with global venture partners.
- Strategic Communication: The ability to explain intricate, highly technical manufacturing data to regulatory reviewers, non-profit foundations, and executive board members.
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.
By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.
