ApplyRegulatory Affairs Specialist - Part Time Contract
Posted 26 days agoInactiveViewed
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Requirements:
- Have an advanced degree BS in a life sciences field, (MS, PhD) preferred
- Good attention to detail, ability to write clear and concise documents
- Interest in regulatory science and how to apply it to company programs
- A broad understanding of drug development and approval processes
- Have some experience in the biotech industry
Responsibilities:
- Assisting in the preparation and submission of regulatory filings including Serious Adverse Event (SAE) reporting and drug shipment notifications for our ongoing clinical trial.
- Providing support with regulatory intelligence activities, including the research of new and existing FDA regulations or guidances.
- Providing support to the regulatory team in responding to inquiries from regulatory agencies.
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