Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high- quality medicines.
Post : Regulatory Affairs Assistant Manager
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 filling
• Preparation and submission of controlled correspondence
• Review and compilation of Annual Report with required submission data as per USFDA guidance.
• Review and compilation of entire supplement/amendment submission package.
• Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames and submissions.
• Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
• Ensure the no delay in drafting and compiling the regulatory submission.
• Maintain regulatory information as per allocated task.
• Having good Regulatory CTD modules drafting & review skills.
Candidate Profile
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred
8 years or more in 8 - 10 Years
Specialized Knowledge : Licenses
Required Skills
• Analytical Thinking & Problem-Solving
• Cross-functional Collaboration
• Data Governance & Compliance
• Policy & Regulatory Intelligence
• Regulatory Compliance
• Regulatory Filings
• Regulatory Reporting & Documentation Oversight
• Regulatory Requirements
• Risk Assessment & Control
• Stakeholder Management
• Strategic & Operational Planning
Additional Information
Experience : 8 - 10 Years
Qualification : B.Pharm, M.Pharm
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th September 2026
Regulatory Affairs Assistant Manager : Apply Online
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