Regulatory Affairs API RA Dept . . in API Division ,
Job Description: ( Regulatory Affairs - API Division )
1. Should have minimum of 2 to 7 years of experience in API regulatory Affairs
2. Thorough knowledge in US, EU and CA regions DMF submission procedures along with emerging markets such as Brazil, Taiwan, Japan, Russia, China etc
3. Should possess good response drafting skills to ensure that the responses to the regulatory queries are properly addressed
4. Should have knowledge and experience in eCTD submissions to US, CA and EU and troubleshooting the issues
5. Thorough review of regulatory submissions prepared by team members and to ensure the correctness of the documents or submissions.
6. Responsible for ensuring and sending response to all the technical queries received from various customers are properly responded as soon as possible.
7. Conducting meetings for the deficiency letters received from various regulatory authorities and tracking of deficiencies with respect to the target timelines and ensure that the response is sent to the authorities as per the stipulated timelines.
8. Participation in the Cross Functional Team (CFT) meetings and guidance to the product development team on regulatory issues.
9. Participation in the Technology Transfer Meetings and ensure that the product is meeting the regulatory requirements.
10. Responsible for ensuring that the regulatory database is properly maintained and updated.
11. Responsible for Review and approval of change control and should ensure that all the approved changes are reported to regulatory authorities.
Drug Regulatory Affairs API RA Dept.