Skills

TOTAL EXPERIENCE

4 years (until July 2019)

COMPUTER SKILLS

Microsoft Office

Documentum (for dossier compilation and review)

Trackwise Software (for tracking dossier and commitment action)

SAP

Current Company:

 DDReg Life Sciences Private Limited (at client location Cipla Limited, Vikhroli)

Joining: September 2018

Department: International Regulatory Affairs (Emerging markets)

Designation: Senior Regulatory Associate

 Responsibilities:

• Compilation and review of Dossier for various countries according to guidelines of respective regulatory authority.
• Preparation of QOS according to guidelines of respective regulatory authority.
• To resolve queries raised by respective regulatory authority and consultant regarding submitted dossier.
• Coordinating with concerned departments like Quality Assurance/ Quality Control/ Production to procure the documents for dossier compilation and meet the submission timelines.
• Product leverage and evaluation from regulated markets as per county requirements.
• Review of all formulation documents starting from raw material specifications till execution of exhibit batches for National market. Handling of Change controls, their review & required supporting data.
• Preparation of SmPC and Package insert. To maintain the country wise dossier status and dossier requirement checklist.

Refrences

Previous Company:

 Swiss Exports Pvt. Ltd.

Joining: August 2016-August 2018

Designation: Regulatory Affairs Officer

Compilation and review of Dossier for various countries according to guidelines of respective regulatory authority.

• To resolve queries raised by any regulatory regarding submitted dossier.
• To file variation and re-registration for Africa countries according to guidelines of respective regulatory authority.
• To execute the allotted work of Dossier preparation and sample management.
• Coordinating with concerned departments like Quality Assurance/ Quality Control/ Production to procure the documents for dossier compilation and meet the submission timelines.
• Maintaining the Dossier and sample entries country wise. Preparation of SmPC, Draft Label, PIL and Package insert. To maintain the country wise dossier status.

 Torrent Research Centre, Bhat

Joining: July 2015-July 2016

Formulation:

• Review of all formulation documents starting from raw material specifications till execution of exhibit batches for National market.
• Handling of Change controls, their review for reviewer’s comment

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