Manager, 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.
Initially reporting to the Senior Vice President of Regulatory Affairs and Quality Assurance, this position is responsible for daily operational activities within Regulatory Affairs to ensure timely and accurate submissions to the FDA/other regulatory authorities and adequate systems to ensure compliance. The ideal candidate will be eager to assist with building the regulatory organization within a growing clinical stage company.
- Liaise and collaborate with external CRO and Fulcrum teams to prepare timely and complete eCTD submissions to FDA and other regulatory authorities.
- Track document preparation and timelines with program management
- Inform of issues, problems, solutions to ensure quality submissions.
- Manage the tactical execution of short- and long-term regulatory objectives to achieve business objectives with minimal supervision
- Oversee the establishment and maintenance of an archiving/document management system.
- Support creation and maintenance of procedures associated with regulatory affairs responsibilities.
- Support budget and contract/invoice oversight associated with external CROs and regulatory consultants.
- Assist with various regulatory projects as assigned.
- Occasionally provide advanced editing/formatting support for regulatory documents.
- Bachelor’s Degree required, with degree in the sciences preferred.
- Minimum 5 years of experience in the pharmaceutical industry; at least 2 years’ personal experience, or working closely with a CRO, with electronic regulatory submission software and systems for IND/CTA/NDA/MAA submissions.
- 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 computer skills and highly proficient in MS Office applications and Adobe Acrobat.
Learn more here
Job posted: 2020-07-20