Amneal Pharma Hiring For Regulatory Affairs Department 

Amneal Pharma Hiring For Regulatory Affairs Department 

Amneal Pharma Job Vacancy Details:

Amneal have opportunity for Regulatory Affairs - Injectable based at Ahmedabad location. Request to find below the required details:

Required Experience: 04-12 Years

Position: Senior Executive / Asst. Manager / Manager

Job Location: Ahmedabad




Job Description:
• Experience in submission of ANDA and FDA query responses for Sterile products, 505b2, Complex products (including Peptides), Drug-Device combination products, and Ophthalmic and Otic Products.

• Review of literature and preparation of Regulatory Strategy for Sterile products development and submission for USA, Europe, and Canada Market
Preparation of Controlled Correspondences, packages for FDA meetings, and Scientific advice.

• Review of documents with respect to compliance with Regulatory guidelines and submission requirements.

• Preparation and submission of the quality dossier/ANDAs within the stipulated timeline.

• Primary review of DMFs and follow up with the concerned team to get all required documentation.

How To Apply for Amneal Pharma Job 

If interested, please share your CV at kavitriy@amneal.com mentioning the subject line "Application for Regulatory Affairs - Injectable"

Freshers and candidate from other departments, please don't apply.