Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad, Gujarat seeks a Regulatory Affairs professional with strong expertise in US FDA/ANDA submissions and post‑approval activities. You'll contribute to filing strategies, coordinate cross‑functional teams, and ensure compliance with ICH and USFDA guidelines across CTD modules.

You will draft, compile, and review submission packages, annual reports, and CBE/ PAS submissions, maintaining regulatory information and timelines to avoid delays in approvals.

Qualifications

• Strong knowledge of US ANDA submissions and post-approval procedures per ICH and USFDA guidelines.
• Experience reviewing change controls against ICH and USFDA guidance.
• Preparation and submission of controlled correspondence.
• Review of annual reports and supplement submissions per USFDA.

Responsibilities

• Coordinate with cross-functional teams to ensure documents are available per submission plan.
• Draft and compile regulatory submission packages with no delays.
• Maintain regulatory information for assigned tasks.
• Ensure timely submission and compliance with regulatory timelines.

Skills

US FDA regulatory submissions

ANDA submission knowledge

Post-approval procedures

ICH guidelines

Regulatory CTD drafting

Cross-functional coordination

Regulatory submission planning

Annual report submissions

Document compilation and review

Dosage forms knowledge

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.