Experience

Arihant Innochem Pvt Ltd - India

• Chemical Manufacturing
• 1 - 100 Employee

• Manager Regulatory & QA

  • Jan 2012 - Present

  Pharmaceutical Excipient Distribution Industries

• Sr. Executive Regulatory & QA

  • Dec 2011 - Feb 2022

  • Handling regulatory requests / queries from customers.• Handling vendor approval requests – filling forms, sharing FAQ, documents etc.• Maintenance of regulatory documentation.• Monitoring and maintaining complaint status redressed file. • Coordinating for Technical Agreements, Audits b/w manufacturers and customers.



Ciron Drugs & Pharmaceuticals Pvt. Ltd.

• India
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Drug Regulatory Affairs Executive

  • Aug 2010 - Jun 2011

  • Dossier preparation for ROW countries as per CTD/ACTD and country specific formats.• Review of DMF and Finished product documents viz. BMR, BPR, Validation protocol and report, Specifications and COA. Preparation of Quality overall summary.• Providing regulatory guidance throughout R&D and manufacturing processes.• Compiling / Writing & submitting regulatory documents in an efficient and timely manner. • Integrate the relevant regulatory policies, guidance’s and procedural requirements into the developmental phase of the multi functional teams. • Follow-up on submissions to ensure final approval in the shortest possible time. • Responsible for responding to any regulatory queries on behalf of the project team with inputs from other team members. • Ensure project work is auditable, complete & error free.• Develop/Review of SOP's, Checklists.