We have multiple opportunities in Regulatory Affairs at Amneal Pharma, Ahmedabad. Please find below details and share your updated CV mentioning “Application for Regulatory Affairs”

Function: eCTD Publishing
Position: Sr. Officer/Executive
Experience: 3-5 Years
Dosage Experience: Solid Oral/Injectable
Job Responsibilities:
1. CTD/ e-CTD compilation, publishing, validation for US submissions
2. Archival and life cycle management of the CTD/e-CTD submission.
3. eCTD Submission Publishing and Submission Management

Function: ANDA Submission (Pre Approval)
Position: Executive/Senior Executive
Experience: 3-7 Years
Dosage Experience: Solid Oral/Topicals
Job Responsibilities:
1. Topical/Transdermal/Nasal/OSD pdt. ANDA life cycle knowledge
2. Compile, prepare, critically review and submit ANDA submissions and Amendments to FDA with an overall objective to receive approval within the shortest timeframes possible. Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
3. Must have expertise/prior experience in Topical/Semi-solid, Liquid-oral, Solid-oral, Nasal dosage form ANDAs.
4. Ensure timely submission of all assigned projects.
5. Ensure final ANDA meets the requirement set forth by US FDA and accepted for review by FDA without query or RTR.
6. Evaluate change controls and formulates strategies for correct filing categories, with guidance from supervisor. Proactively raises major project issues if any to superior for resolution and agreement. 7. Compile and submits critical post-approval supplements, such as CBE, CBE-30 and PAS as and when necessary.

Function: ANDA Submission (Pre Approval)
Position: Executive/Senior Executive/Assistant Manager/Manager
Experience: 4-8 Years
Dosage Experience: Injectable
Job Responsibilities:
1. ANDA submission for Injectable Infusion bag and Injectable products, Amendment submission Regulatory target preparation
ANDA preparation & Query responses. Ensure timely submission of all assigned projects.
2. To prepare and file ANDA & Query responses.
3. ANDA, Amendment, Supplement, Annual Report submissions
4. ANDA submissions Amendment Submission Regulatory strategy preparation
5. To handle ANDA submissions activity at India for US site projects
Compile, prepare, critically review and submit the US ANDAs
6. Work very closely with US regulatory Project manager at the time of product initiations, R&D phase, and after initiation of stability to ensure timely availability of all documents to ensure timely submissions.
7. To prepare and file ANDA & Query responses.