O2 Technologies,Inc
US Regulatory Lead
Skills
2 months ago
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Important information
Contract type:
Freelance / Contract
Location:
Cambridge, MA, USA
Work mode:
Remote
Published on:
25 August 2026
What they need
Key Responsibilities & Skills
- US FDA Regulatory Requirements
- IND / NDA / BLA Submission Management
- Regulatory Research & Intelligence
- Cross-Functional Team Representation
- Process Mapping & Authoring for Submissions
- External Innovation Assessment (Regulatory)
- Oncology & Neurology Therapeutic Knowledge
- Project Deliverable Coordination
- Regulatory Strategy Development
- US Regulatory Compliance
Technical Skills
- eCTD / FDA Submission Portal
- Regulatory Intelligence Tools
- Document Management Systems
Education
Bachelor's Degree (BS/BA) in Pharmacy, Pharmacology, Biology, Chemistry, Biomedical Sciences. Preferred: Master's Degree (MS), PhD, PharmD, MBA.
Industry Experience
- Pharmaceuticals
- Oncology
- Neurology
- Clinical Development
- Regulatory Affairs
#CareerOpportunities #JobVacancy #WorkWithUs
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