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Iffat Kalsekar

Iffat Kalsekar

Regulatory Affairs Senior Associate

Pharmaceutical / Bio-tech

Leicester, Leicester

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About Iffat Kalsekar:

Ambitious and self- driven professional with more than 15 years of extensive Pharmaceutical Industry related experience within Regulatory Affairs, Quality Control, Quality Assurance and R&D, with proven ability to work collaboratively with cross-functional teams, stakeholders, and regulatory authorities. 

Provided EU regulatory support, ensuring scientific accuracy and compliance with industry guidelines, resulting in successful EU marketing authorisation application (MAA) submissions and approvals

Acquired MTOPRA certification as a testament to my commitment to maintaining my CMC expertise and knowledge.

Experience

Ambitious and self- driven professional with more than 15 years of extensive Pharmaceutical Industry related experience within Regulatory Affairs, Quality Control, Quality Assurance and R&D, with proven ability to work collaboratively with cross-functional teams, stakeholders, and regulatory authorities. 

Provided EU regulatory support, ensuring scientific accuracy and compliance with industry guidelines, resulting in successful EU marketing authorisation application (MAA) submissions and approvals

Acquired MTOPRA certification as a testament to my commitment to maintaining my CMC expertise and knowledge.

Education

Masters in Biomedicine 

Bachelor of Pharmacy

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