Amneal Pharm Hiring For Regulatory Affairs

Amneal Pharm Hiring For Regulatory Affairs

Amneal Pharmaceuticals, Inc. (NYSE: AMRX)

Job Location: Ahmedabad

We are looking for candidates with relevant experience as mentioned below:

Department: Regulatory Affairs

Designation: Executive / Senior Executive

Qualification: B. Pharm / M. Sc. / M. Pharm

Experience: 2-7 Years

Required Skills:

Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.

API DMF review with respect to USFDA regulatory requirements.

Exposure to the solid oral dosage form/sterile dosage form/complex dosage form/topical-inhalation dosage form and brief manufacturing process and key regulatory aspects.

Ability to preliminary review change cases with respect to ICH quality/post-approval USFDA guidance and aware for post-approval submission guidance 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.

Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.

Awareness about the FDA recommendation on commercial marketing status notification submission in terms of content and time frames.

Interested candidates can share their CV on below mail IDs:

kavitriy@amneal.com and yash.ojha@amneal.com

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