Sr. Executive / Executive- Plant Regulatory Affairs

Role & responsibilities :

Review of all QMS documents related to regulatory submissions

• Prepare status of all documents related to submission
• Co-ordinate with all stakeholders of plant for collection of documents
• Provide all regulatory documents to HO-RA for submission.
• Evaluation of change control, deviations and out of specifications.
• Review of specifications, BMRs, BPRs, COA, Method transfer report, Method verification/validation report, Analytical chromatograms, Sterility assurance data package.
• General Review of plant equipment qualifications, filter validation documents and layouts for its adequacy to support regulatory submission.
• To facilitate LoA, Debarment certificate, GMP certificate with Internal Teams and for external labs / manufacturing facility in collaboration with vendor qualification and/or supply chain team
• Support plant team for all regulatory audit
• Communicate with customer regulatory team for document submission and change control approval.
• Guide plant team for good documentation practice requirement for submission
• Respond all queries of customer on time
• Evaluate all post-approval changes and prepare variation package and share with client
• Good communication skills and drafting of dossier
• Well aware about Microsoft (Word, Excel and Power point) skills