Regulatory Operations Associate Precision for Medicine

1.0 - 5.0 years

0 Lacs

karnataka

On-site

As a Regulatory Administrator at our company, you will play a vital role in providing administrative and operational support to the Regulatory Affairs department to ensure the smooth facilitation of the regulatory submissions process. Your responsibilities will include: - Uploading, organizing, and maintaining regulatory documents within various regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and ensuring compliance with global standards. - Collaborating with external vendors for document redaction services and monitoring the progress of redaction processes. - Assisting in preparin...

Posted 2 months ago

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Senior Regulatory Operations Associate Precision for Medicine

3.0 - 7.0 years

0 Lacs

karnataka

On-site

The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fosterin...

Posted 3 months ago

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