Executive, Regulatory Affairs

Amneal Pharmaceuticals LLC; India; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a regulatory affairs specialist to support ANDA submissions and post-approval activities, aligned with ICH guidelines and USFDA requirements.

You will review DMFs, prepare change notifications, draft annual reports, and coordinate cross-functional teams to ensure timely regulatory submissions.

The role requires strong drafting skills in CTD modules and the ability to prepare briefing packages for FDA as needed.

Responsibilities

• Good knowledge of ANDA submission activities and post-approval procedures per ICH and USFDA guidelines.
• Review API DMF and DMF Change Notification with respect to USFDA regulatory requirements.
• Exposure to solid oral dosage forms, sterile dosage forms, complex dosage forms, topical/inhalation forms and brief manufacturing processes and key regulatory aspects.
• Preliminary review of change cases with respect to ICH quality and post-approval USFDA guidance; aware of Post approval submission guidelines and annual report/CBE 0/CBE 30 and PAS filing.
• Drafting of the Annual Report with required submission data as per USFDA guidance.
• Preliminary review of entire submission package.
• Drafting of controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
• Awareness about FDA recommendations on commercial marketing status notification submissions in terms of content and time frames.
• Coordination with cross-functional teams for document availability as per regulatory submission plan.
• Ensure no delay in drafting and compiling regulatory submissions.
• Maintain regulatory information as per allocated task.
• Having good Regulatory CTD modules drafting & preliminary review skills.

Job description

• Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
• Exposure of the Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation 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.
• Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
• Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
• 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.