Director, Regulatory Affairs CMC

Company Overview

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined diseases in areas of high unmet medical need. Fulcrum’s proprietary patient-focused product engine is designed to systematically identify and validate cellular drug targets that can modulate gene expression to treat the root cause of genetically defined rare diseases.

Description

Reporting to the Chief Regulatory and Quality Assurance Officer, the Director RA CMC will be responsible for leading the development, implementation, and advising on domestic and global chemistry, manufacturing, and control regulatory (RA CMC) strategies to secure and maintain both clinical access and market access for product(s) in line with business objectives. The successful individual will provide RA CMC expertise, lead the preparation and review of CMC regulatory submissions, and collaborate with key internal stakeholders through various phases of development, post-approval, and life cycle of the product.

Responsibilities

• Lead the development and execution of domestic and global RA CMC submission strategies and timelines in collaboration with CMC/Technical Operations, Regulatory Affairs, and Quality Assurance colleagues.
• Assess and communicate RA CMC requirements, risks, and mitigation strategies to ensure compliance with applicable regulations and guidelines.
• Lead the preparation, team review, and submission of CMC content across all phases of development for INDs/IMPDs/CTAs, and NDAs/MAAs.
• Liaise with global health authorities and lead meeting preparations for RA CMC matters.
• Maintain knowledge of current and emerging FDA/ICH CMC regulatory requirements and guidelines, and share relevant information with internal stakeholders.
• Manage RA CMC vendors and consultants.
• Contribute to the evaluation of potential in-licensing candidates, partnerships, and due diligence activities.

Qualifications

• Bachelor's degree in life sciences required; advanced degree preferred.
• Minimum of 10 years in RA CMC. Advanced degree preferred.
• Expertise in small molecule drug development; rare disease experience preferred.
• Strategic thinking and tactical skills required.
• Good understanding of FDA and ICH requirements and guidelines, with experience interacting with regulatory agencies; knowledge of EU and other health authority CMC requirements is a plus.
• Ability to work effectively as part of a team and as an independent contributor.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent interpersonal and communication (written and verbal) skills.
• Proficiency in MS Office applications, Adobe Acrobat, and project management tools.