Careers

·       Perform different submissions for IND, NDA, BLA, DSURs, Agency Meetings, health Authority     meetings and CMC amendments for all Oncology products.

·       Responsible to be part of meeting discussions at onsite, and coordinate with Global regulatory  strategists, publishing team (Submission specialist) and CMC team to be submitted in timely manner.

·       Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.

·       Part of Meeting discussions at Onsite with client.

·       Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA.

·       Coordinate with Global regulatory strategists, publishing team (Submission specialist) and CMC team, SME so that the filings or submissions could be dispatched in timely manner.

·       Once the labeling and annual reports are submitted to Division, the status should be marked as  submitted and submitted date should be provided to be compliant with the annual reports and labeling submissions.

·       Perform archiving the complete submission with their Sequence numbers in Contact Database for  ongoing purpose.

·       Arrange meetings with the GRS and Clinical developments team to ensure the IB and Annual  reports are submitted with due diligence and provide the template to the team.

·       Prepare the cover letter and FDA forms for all different submissions and sign them to import to the Virtual document.

Qualification:

This position requires a minimum of a Bachelor’s degree in Biomedical Engineering, or administration with a concentration in management, business or related or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.