Regulatory Affairs

Role & responsibilities

1. Authoring / writing and review of CMC sections of dossier

2. Critical review of design stage documents (specifications, controls and protocols) to ensure that regulatory requirements are fulfilled

3. Co-ordination for collection of post-execution data from various functions and review for compliance against the design specifications, controls and protocols.

4. Collaboration with various cross functional team members for timely conclusion of action items identified for responding deficiencies.

5. Review and to check the accuracy of information in various status and database maintained at department / company level

6. Ensure compliance of regulatory submissions with current regulations and guidance

7. In depth understanding of regulatory requirements and Health Agencys expectations

8. Contributes individually or manage the team / subordinates effectively to ensure that target submissions are achieved in time

9. Train and develop individuals to achieve department and company goals