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Amneal Pharmaceuticals

Executive, Regulatory Affairs

Amneal Pharmaceuticals
Ahmedabad, India
5-8 Years
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  • Posted 17 days ago
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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:

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceuticals
Employment Type:
Full time

Job ID: 149333479

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Last Updated: 20-06-2026 05:14:12 PM
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Executive, Regulatory Affairs

Amneal Pharmaceuticals
Ahmedabad, India

Skills:

post-approval procedures, Solid oral dosage form, Regulatory CTD modules drafting, topical-Inhalation dosage form, regulatory aspects, CBE 30, USFDA guidelines, Sterile dosage form, DMF Change Notification review, complex dosage form, CBE 0, ANDA submission activities, Manufacturing Process