Associate Director, Regulatory Affairs

About Fulcrum Therapeutics

Fulcrum Therapeutics, Inc. (“Fulcrum”) [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum’s lead program in clinical development is pociredir, a small molecule designed to increase the expression of fetal hemoglobin for the treatment of sickle cell disease (SCD).

Description

Reporting to the Executive Director Regulatory Affairs, this role will provide strategic leadership and support on regulatory submissions, manage global regulatory timelines, and ensure compliant and efficient execution of regulatory activities across development stages and product lifecycles. The ideal candidate will have an understanding of global regulatory requirements (FDA, EMA, ICH, etc.), hands-on experience in electronic submissions, and a collaborative mindset to drive cross-functional success. The ideal candidate will be eager to assist with building the regulatory organization within a growing clinical stage company.

Responsibilities

• Oversee planning, preparation, review, tracking and submission of high-quality regulatory dossiers (e.g., INDs, CTAs, NDAs, MAAs).
• Provide guidance to cross-functional teams to ensure submissions comply with applicable regulations, standards, and agency guidance, including clinical, nonclinical, CMC, and commercial stakeholders.
• Coordinate responses to CTA queries from regulatory authorities (e.g., FDA, EMA, MHRA, Health Canada, TGA), when required.
• Track regulatory questions, commitments, and timelines using internal systems and ensure timely escalation of issues.
• Coordinate publishing, formatting, and archiving of submissions and regulatory correspondence in compliance with internal SOPs and health authority requirements.
• Liaise with external vendors to manage regulatory timelines, document control, and submission logistics using industry-standard publishing tools.
• Act as the primary liaison with internal submission teams, external vendors, and regulatory authorities for operational matters.
• Oversee the archiving of regulatory submissions and correspondence and serve as administrator of the Regulatory Information Management system.
• Contribute to process improvements and best practices for regulatory submissions.

Qualifications

• Bachelor’s Degree required, with degree in the sciences preferred. Master’s degree preferred.
• Minimum 8 years of experience in the pharmaceutical or biotech industry; at least 3 years’ experience, or working closely with a CRO, with IND/CTA/NDA/MAA submissions.
• Expertise in regulatory operations including eCTD submissions, regulatory publishing tools, and document management systems.
• Able to successfully manage and prioritize complex projects to deadlines with relative independence; organized and adaptable to address conflicting deadlines in a dynamic drug development environment.
• Demonstrated attention to detail and follow-through on assigned activities.
• Outstanding interpersonal and communication (written and verbal) skills; demonstrates calm, professional, diplomatic and positive behaviors.
• Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
• Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat