Regulatory Affairs Associate

Responsibilities

Preparation, review, and timely submission of ANDA and ANDS in US and Canada market.

Deficiency and life cycle management for the products filed in US and Canada.

Review of technical (developmental and plant) documentations required for dossier submission.

Providing necessary regulatory inputs to different cross functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.

Publishing the necessary regulatory dossiers in eCTD format as per the country requirement.

Maintaining the necessary regulatory databases concurrently as on when regulatory updates are received.

Responsible to understand the requirements related to US and Canada regulatory submissions.