Executive Regulatory Strategy Consultant

Overview
We are seeking a seasoned regulatory consultant to provide strategic guidance and operational support across regulatory workstreams. The consultant will partner closely with the Chief Medical Officer and cross-functional teams to ensure alignment with FDA expectations and readiness for key milestones, including FDA meetings and BLA submission.

Ideal Background

• Former FDA or Senior Regulatory Affairs Leader with direct experience in biologics, cell/gene therapy, or regenerative medicine.
• Proven track record supporting successful Biologics License Applications (BLAs).
• Cross-functional fluency across Clinical, CMC, Nonclinical, Biometrics, and Quality functions.
• Expertise in expedited pathways (Fast Track, Breakthrough Therapy, RMAT, Priority Review).

Key Competencies

• Regulatory Strategy & Guidance : Advises on U.S. regulatory requirements, pathways, and risk mitigation.
• FDA Meeting Preparation : Drafts, reviews, and refines briefing packages; coaches teams on conduct and messaging.
• BLA Submission Support : Provides readiness assessments, quality control, and coordination across functional teams.
• Regulatory Documentation : Drafts and reviews correspondence, ensuring compliance with FDA, ICH, and global standards.
• Cross-Functional Collaboration : Partners with internal teams and external CROs/vendors to drive alignment and execution.

Consulting Style

• Executive Presence : Confidently engages with senior leadership and regulatory authorities.
• Collaborative Operator : Balances diplomacy with authority in cross-functional settings.
• Gap Identifier : Proactively spots weaknesses and provides actionable solutions.

Deliverables

• Written or verbal regulatory strategy advice
• FDA meeting materials (drafts, reviews, coaching)
• Submission readiness feedback and gap assessments
• Regulatory correspondence drafts or reviews
• Participation in internal/external meetings

Experience Requirements

• Minimum 8-12 years in regulatory affairs or related roles within biologics, cell/gene therapy, or regenerative medicine.
• Proven leadership in managing regulatory submissions, especially Biologics License Applications (BLAs).
• Direct experience interacting with FDA, preferably CBER or CDER.
• Demonstrated ability to lead cross-functional teams and influence senior stakeholders.
• Experience with expedited regulatory pathways such as Fast Track, Breakthrough Therapy, RMAT, and Priority Review.

Education Requirements

• Advanced degree (MS, PhD, PharmD, or MD) in life sciences, pharmacy, medicine, or related fields.
• Formal training or certification in regulatory affairs is highly desirable (e.g., RAC certification or specialized cell/gene therapy regulatory courses).

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.