Director of Regulatory Affairs
Job Summary
To support the expansion of innovative therapies, the full-time Director of Regulatory Affairs will develop and implement US regulatory strategies, serve as the primary contact with the FDA, and oversee critical regulatory submissions while working remotely.
Key responsibilities:
- Develop and implement robust US regulatory strategies for assigned projects
- Serve as the primary contact with the FDA and manage all health authority interactions
- Lead the preparation of regulatory submissions, ensuring compliance with regulatory requirements
Required qualifications:
- Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, including 5-7 years in global leadership roles focused on FDA
- PhD or PharmD preferred
- Thorough understanding of the drug development process, particularly with orphan drugs
- Experience interacting with regulatory authorities and managing critical regulatory documents
- Strong leadership skills with experience in team building and mentoring
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