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SENIOR DIRECTOR, REGULATORY AFFAIRS
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ClinLab Staffing - Boston 2 days ago
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Go to next pageDiscover International - Boston
Work at Discover International
We are collaborating with a clinical-stage biotechnology organization dedicated to advancing treatments in the immunology space through its innovative auto-immunology-focused pipeline.
Responsibilities:
- Serve as the Head of Regulatory for the group
- Develop and implement global regulatory strategies for assets spanning early to late-stage clinical development.
- Coordinate with late-phase regulatory teams to ensure global compliance, facilitate smooth transitions, and establish a strong foundation for BLA submissions.
- Lead interactions with health authorities.
- Oversee the preparation, review, publishing, and submission of regulatory documents to global agencies (FDA, EMA, PMDA, etc.).
Qualifications:
- 8+ years of experience in U.S. Regulatory Affairs, preferably within the biotechnology sector.
- Comprehensive expertise in regulatory submissions across various areas.
- Strong background in biologics with a track record of successful submissions.
- Experience in immunology is highly desirable.
If you have the expertise and passion for driving regulatory strategy in immunology, we’d love to hear from you. Apply today to be part of a team making a meaningful impact in the field.
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Senior Director Regulatory Affairs
