Assistant/Deputy Manager-Regulatory Affairs(US Mkt-Formulations)

Dear All,

We are looking for a Regulatory Affairs Assistant Manager/Deputy Manager with 7-10 years of experience in pharmaceutical formulations, specifically for the US market.

Key Responsibilities:

• Defining Regulatory strategies for submission for US market
• Review of team who are responsible for preparation and compilation of the dossiers in CTD/eCTD and other formats as required for submission to different regulatory authorities.
• Review of dossiers in CTD/eCTD for US market.
• Review & approval of Batch Records, Specifications and STP etc.
• Responding to queries /deficiencies received from regulatory authorities.
• Monitoring of timely submission of Labeling Initials, Amendments, Labeling Supplements and Annual Reports.
• Responsible for life-cycle management of regulatory submissions.
• Responsible for preparation and maintenance of all the documents related to the regulatory submissions.
• Coordinate and supports all concerned departments with respect to the required documents for submission purpose.
• Training the line function in updating the current guidelines and requirements.

Note: Interested candidates can share their resumes to raghuveera.vutla@aizant.com