Amneal Pharmaceuticals
Ahmedabad, IN · On-site · Full-time
Assistant Manager, Regulatory Affairs
Posted 23 days ago
- Location
- Ahmedabad, IN
- Work mode
- On-site
- Employment
- Full-time
- Experience
- Lead
About the role
Job Description Good knowledge of US ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Solid oral dosage form/Liquid Oral/Transdermal dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to review the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS fill…