Regulatory Affairs Associate
The Regulatory Affairs Associate will manage the coordination, compilation, review and submission of routine regulatory post-approval submissions,
and contributes to more complex submissions such as ANDAs.
- Compile and submit Annual Report as per yearly schedule.
- Compile and submit quarterly and annual adverse drug experience (ADE)reports as per yearly schedule.
- Compile and submit 15-day alert report as required.
- Arrange and maintain the RA library.
- Assist in projects assigned for post-approval affairs.
- Review and keep tracks of labeling revisions for post-approval products, including tracking RLD updates.
- Bachelor's degree in Regulatory Affairs or related coursework.
- Working knowledge and experience with 21 CFR cGMPs.
- Strong computer skills.
- Ability to communicate effectively and collaboratively as part of a team.
- Ability to interface professionals domestically and abroad.
We offer a comprehensive compensation package which We offer a comprehensive compensation package which includes Health Insurance and an employer-matched 401(k) plan.
Qualified candidates should email a resume, including salary history and requirements, to