Executive, Regulatory Affairs

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Regulatory Affairs professional with strong knowledge of ANDA submission activities, post-approval procedures, and ICH/USFDA guidelines. The role involves coordinating regulatory submissions, drafting annual reports, and ensuring timely compilation of CTD modules.

Candidates should have a B. Pharm and 5–8 years of experience in regulatory affairs, with preference for M. Pharm, and exposure to sterile dosage forms and CBE/PAS processes.

Qualifications

• B. Pharm degree is required.
• M. Pharm degree is preferred.
• 5–8 years of experience in regulatory affairs.

Responsibilities

• Knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
• Review of change cases with respect to ICH quality / post-approval USFDA guidance and awareness of Post-approval submission guidelines (Annual report/CBE 0/CBE 30 and PAS filing).
• Drafting of the Annual Report with required submission data as per USFDA guidance.
• Coordination with cross-functional teams for documents availability as per regulatory submission plan and ensure no delays in drafting and compiling regulatory submissions.

Education

Bachelor of Pharmacy (B.Pharm)

Master of Pharmacy (M.Pharm)

Job description

Description

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.

Education

QUALIFICATIONS

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 5 years or more in 5 - 8 Years

Specialized Knowledge:

Licenses: