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 : Executive, Regulatory Affairs
Job Description
• Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects.
• Ability to preliminary 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
• Drafting of the Annual Report with required submission data as per USFDA guidance.
• Preliminary review of entire 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 & preliminary review skills.
Additional Information
Experience : 5 - 8 Years
Qualification : B.Pharm, M.Pharm
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th September 2026
Regulatory Affairs Executive : Apply Online
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