Associate Regulatory affairs
Job Location:
Monthly Salary:
Posted on:
4 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
First-time filing experience: hands-on authoring review and submissions for initial filings in the US and EU
(e.g. IND ANDA NDA BLA MAA).
2. Health authority queries: hands-on management including data gathering and drafting of responses.
3. Source data review: hands-on review of source data from R&D manufacturing and related functions.
4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.
(e.g. IND ANDA NDA BLA MAA).
2. Health authority queries: hands-on management including data gathering and drafting of responses.
3. Source data review: hands-on review of source data from R&D manufacturing and related functions.
4. Lifecycle management: demonstrated experience with post-approval lifecycle activities in the US and EU.
