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About Company

Position Name :

Organization :





Location: Ahmedabad Corporate Office

Position Overview:

Big Pharma is seeking a talented and experienced individual for the role of AM / DM in Regulatory Affairs (API) focused on the US Market (DMF Filing). This role is essential for our corporate team and requires specific expertise in regulatory affairs for APIs.

Key Responsibilities:

  • Conduct technical reviews of API DMFs for the US market.
  • Prepare ANDA Drug Substance Modules and respond to deficiencies.
  • Review API Nitrosamine Risk Assessment Reports.
  • Utilize strong technical writing, communication, and presentation skills.


  • Current Designation: Senior Executive (minimum 2 years) or Assistant Manager and above.
  • Must have experience in corporate regulatory affairs. Plant RA experience is not required.
  • Proven experience in regulatory affairs for APIs.

How to Apply:

Interested candidates are invited to share their CV via email or WhatsApp.

  • Email: swati.bigideashr@gmail.com
  • WhatsApp: 9871855807

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