RA Project Manager-API

1.

Coordinate with the regulatory team based in India and translate the DMF shared from Indian office in regional language for submission as per the given timeline

2.

Translate the amendment and annual reports that are shared by Indian office

3.

Responsible for tracking of queries and letter of access issued to various customers

4.

Coordinate and ensure the sample requirement from India to Regulatory authorities as per the timelines and maintain the tracker for the samples shared with agency.

5.

Follow up the open issues for the new submissions and ensure the closure with the Indian regulatory team

6.

Write the CDs DVD’s of the Applicant’s Part DMF and courier it to customers

7.

Take up the administrative activities such as courier of the Applicant’s Part DMF, Letter of access, original declaration to customers and agencies and to India office

8.

Follow up with the business team for the payment of the fee to the agents and agency.

9.

Prepare the necessary presentations required for the department and organization

10.

Maintain good knowledge in general/product specific scientific and regulatory requirement/ process.

11.

Maintain strong working

Requirements:

1.

Bachelor or Master Degree in pharmacy or related discipline.

2.

1-2 years of working experience in imported API registration/Relevant RA experience.

3.

Familiar with requirement of procedure about DMF filling and registration testing issued in

2020.

4.

R&D/Quality working experience is priority.

5.

Good communication, quick learner. Experienced in MS office operation.

6.

Good at English writing, reading and speaking.

7.

Ability to handle multi-task activities.