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Find out how your skills align with the job description
Skills
Do you have experience in Regulatory submissions?
Education
Do you have a Master’s degree?
Responsibilities:
- Identifies, obtains, compiles, authors and reviews regulatory documents concerning combination products and CMC-related issues that are needed for FDA submissions including IND and NDA/BLA submissions, NDA supplements and briefing packages for agency meetings and regional approvals.
- Answers Information Requests (IR) generated during submission review cycles.
- Development of regulatory strategies, timelines and plans for the combination product development platform.
- Preparation of annual reports and keep other annual updates or reports current.
- Review and assess the regulatory…
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