Officer

Job Description

To provide all the necessary support to corporate RA for regulatory submissions for all countries.  
To share the regulatory deficiencies with concerned Departments and provide related response and documents to Corporate RA for further action. 
To ensure Regulatory compliance by providing required documentation for the submission of DMF amendments, supplements/variations and timely Annual Updates. 
To review and approve applicable Quality system related documents, Master documents and review of Executed documents. 
Approval of documents after consulting with Manager- Site /Corporate Regulatory Affairs. 
To develop systematic tool for tracking of Regulatory documents and information submitted as per commitment and active participation in department development activities. 
Evaluation of post approval changes for impact assessment and regulatory submissions. If required consult Corporate RA and co-ordinate with other departments to understand the regulatory submission strategies.

Work Experience

1 to 2 Years of Expereince

Education

Competencies