Associate Director/Director, Regulatory Affairs
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.
Reporting to and in partnership with the Senior Vice President of Regulatory Affairs and Quality Assurance, this position will be responsible for developing, implementing, and advising on domestic and global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life cycle of the product.
- Liaise and collaborate with external CRO and Fulcrum teams to set up investigational trial applications in and outside of the US.
- Provides high level strategic and operational regulatory direction on projects both domestically and globally.
- Uses extensive knowledge of US, EU and ICH regulatory requirements to support project objectives and business goals.
- Oversees the preparation and submission of documentation to support investigational and registration packages throughout the world and ensures timelines are met.
- Reviews sections of IND/CTA, NDA/MAA, and other global submission documents in support of clinical trials, and their amendments in conformance with local regulatory requirements.
- Liaises with FDA and partners with CRO’s (ex-US) to navigate regulatory communications and strategies.
- Maintains awareness of global regulatory environment and regulatory precedents to assess potential impact on product development programs.
- Builds partnerships with stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Regulatory representative on the program team for assigned products.
- At least 10 years of Drug Discovery experience, 5-7 years’ experience in Regulatory Affairs.
- Strong strategic skills and the ability to thrive in a dynamic small-team environment with a willingness to perform additional tasks outside of the duties listed above.
- Experience with electronic regulatory submission software and systems, IND/CTA/NDA/MAA submissions, eCTD format.
- Rare Disease experience preferred but not required.
- 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.
- Committed to working alongside cross-functional colleagues as part of highly functioning teams.
- Strong computer skills and highly proficient in MS Office applications and Adobe Acrobat.
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Job posted: 2020-07-20