Director of Regulatory Affairs
Director of Regulatory Affairs
Savara Inc.
United States
See who Savara Inc. has hired for this role
Company Description
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. Our lead program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Visit our website at www.savarapharma.com for more information and learn about the Phase 3 IMPALA-2 clinical trial in aPAP at www.impala2.com.
Role Description
This is a full-time remote role for a Director of Regulatory Affairs. The Director of Regulatory Affairs will be responsible for supporting regulatory strategy and submissions, ensuring compliance with regulatory requirements. This role will involve day-to-day tasks such as overseeing regulatory activities, coordinating with internal and external stakeholders, and staying updated on relevant regulations and industry trends.
Qualifications
- Regulatory Requirements and Regulatory Strategy skills
- Experience in Regulatory Affairs and Regulatory Submissions
- Strong understanding of U.S. and Canadian regulatory frameworks and processes
- Excellent communication and interpersonal skills
- Attention to detail and ability to manage multiple priorities
- Ability to work independently and remotely
- Experience in the biopharmaceutical industry
- Advanced degree in a relevant field (e.g. Pharmacy, Life Sciences, Regulatory Affairs)
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Employment type
Full-time
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