Regulatory Associate - Trainee
Job Description
We are looking for a Regulatory Associate. The successful candidate will:
- Understand the requirements of various regulatory submissions including: IND, ANDA, NDA and DMF in CTD/eCTD formats for various regulatory agencies including: US-FDA, EMA, Health Canada, etc.
- Assist Regulatory Associates/Senior Regulatory Associates with document level publishing, including bookmarking, hypertext linking, and preparing Tables of Contents as per the guidelines.
- Provide Submission Publishing Support, archiving and/or review of same day dispatch, major/complex submissions
- Be compliant with customer SOP's and Policies as well as adhering to the organization's policies and procedures
Desirable Skills and Experience
- Experience in Publishing and Submissions is required
