Obsidian Therapeutics is seeking a Director, Clinical Regulatory to lead clinical regulatory strategy for OBX-115, owning the clinical components of our global regulatory plan and serving as the key executor for clinical regulatory submissions and projects.
Requirements
- Plan, prepares, and review clinical submissions to regulatory authorities.
- Oversee preparation and submission of End-of-Phase (EOP) meeting materials.
- Manage Draft Label development for OBX-115 and ensure compliance with regulatory standards.
- Complete and submit Pediatric Study Plan in accordance with regulatory requirements.
- Lead regulatory activities for Australia and Canada submissions related to pivotal clinical studies.
- Ensure timely and accurate generic and proprietary name submissions as required.
- Provide oversight for protocol amendments and ensure regulatory compliance throughout clinical trial lifecycle.
- Evaluate and recommend improvements to the Regulatory Management System for efficiency and compliance.
- Lead development and maintenance of the Global Regulatory Plan, ensuring alignment with CMC regulatory strategy and overall forward-looking objectives.
- Develop comprehensive Pre-BLA and BLA submission plans to support product approval timelines.
- Collaborate with internal stakeholders (CMC Regulatory, Clinical Development, Clinical Operations, Tech Ops, Regulatory Affairs leadership) to ensure integrated regulatory strategies.
- Act as a key advisor on regulatory implications for clinical development decisions.
- Represent clinical-regulatory on cross functional teams
- Author regulatory documents in a hands-on manner; manage review, roundtables and incorporation of feedback.
- Own regulatory project timelines in partnership with project management
- Contribute to regulatory agency meeting timing and strategy in conjunction with head of regulatory with CMC regulatory input.
- Interact with regulatory agencies as needed
Benefits
- Comprehensive medical, dental, and vision coverage
- Company contributions to health savings and retirement accounts
- Ample paid time off
- Access to wellness programs
- Rich career growth opportunities
- Annual incentive bonus
- Long-term incentives in the form of employee stock options
