Assistant/Deputy Manager-Indian Regulatory (Drug Licenses)

Brief team/department description:

Our Administration team at Azurity Pharmaceuticals always strive for the excellence in all the facilities that were being provided for the Employees. We always look for dynamic personnel who bring a change in the approach and contribute to organizational excellence. The team has diversified responsibilities like lab administration management, Procurement, EHS Indian Licensing.

Principle Responsibilities:

This should specifically outline, in bullet form, the responsibilities of the job:

Licensing activities -

• Preparation and uploading of a suitable application for test license, NOC, Import Licenses as per the guidance of CDSCO DCA.
• Preparing and applying in a suitable application for Narcotics/ control substance for Import licenses / No Objection Certificates from CBN, Gwalior.
• Securing support documents from the respective formulation team for the preparation of applications.
• Coordination with respective regulatory authorities and query response.

Stability Activities -

• Stability chambers management like continuous monitoring of chamber performance maintenance including period qualifications.
• Stability Protocol execution like loading and unloading samples of in coordination with formulation team.
• Stability chamber data review and Alarm acknowledgment on day to day basis as per the SOP
• Documents management of related activities.

General Activities -

• Ensure completion of the required training courses and perform only those activities for which training has been completed, where required.
• Planning day-to-day activities and coordinating with interrelated departments.

Qualifications and Education Requirements -

• This section should include relevant qualifications and education requirements.
• 8 to 10+ years of experience as a Working Professional in a similar field.
• Shall hold any bachelor s or Master s degree relating to Pharmaceutical / life sciences