Assist in the preparation and compilation of domestic and international product submissions, with guidance.
Requirements:
- Bachelor's degree in Regulatory Affairs, Pharmaceutical/Health/Life science or related field
- 3 years of experience with regulatory affairs
- Experience must include 3 years each of the following:
- Preparing and leading IND submissions in the pharmaceutical industry for FDA
- US FDA regulatory affairs
- Drug development process for human use and regulatory requirements of FDA and OUS
- Compliance with regulatory guidance documents
- Identifying regulatory scientific data needs
- Solving regulatory issues
Experience may be gained concurrently. Remote Position.
Application Instructions:
To apply, please send resume via email to Ebird@ocutx.com or mail to:
Ocular Therapeutix, c/o Erin Bird
15 Crosby Drive
Bedford, MA 01730
Please reference job title (Senior Manager, Regulatory Affairs).
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