Head of Regulatory Affairs
3 weeks ago
- Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next.
- Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early compounds.
- Collaborate closely with the Vice President Clinical Science and Chief Medical Officer (CMO) to provide expert consultation on best regulatory practices for upcoming submissions, ensuring alignment with strategic objectives and timelines.
- Oversee regulatory activities related to Huntington's disease (CNS) and early oncology trials, offering strategic guidance and expertise to navigate complex regulatory landscapes.
- Take a hands-on approach to CMC (Chemistry, Manufacturing, and Controls) regulatory matters, ensuring compliance with relevant guidelines and regulations. Extensive experience in CMC regulatory is desirable, but not essential.
- Manage vendor relationships effectively, coordinating regulatory activities with external partners and ensuring alignment with project timelines and deliverables.
- Review and, if necessary, edit critical regulatory sections of documents to ensure accuracy, completeness, and compliance with regulatory requirements.
- Spearhead the development of a future regulatory affairs team, providing mentorship and guidance to team members as the company grows.
- Demonstrate resilience and assertiveness in interactions with the FDA, advocating for our innovative therapies and proactively addressing regulatory challenges to ensure timely approval and market access.
- Facilitate communication with the FDA, serving as the primary point of contact for regulatory inquiries, submissions, and interactions.
- Ensure minimal delays in the initiation of new clinical trials and optimize trial design to maximize efficiency and effectiveness across all phases of development (Phase 0 to III).
- Provide guidance and oversight to Contract Research Organizations (CROs) and consultants involved in regulatory activities, ensuring high-quality deliverables and adherence to regulatory requirements.
Required Qualifications:
- Extensive experience interacting with the FDA, including direct involvement in regulatory submissions and interactions.
- Previous experience working with Oncology or CNS (Central Nervous System) drugs in a regulatory capacity.
- Comprehensive understanding of the biotech industry, with a balance of hands-on regulatory work and strategic thinking.
- Extensive work with most (ideally all) stages of drug development - IND submissions through Phase III.
- Ideal - but not essential - familiarity with clinical quality standards and practices.
- Highly preferred but not essential - experience with Regulatory Agencies in Europe and Asia.
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