Banu Ramachandran Email & Phone Number | Current Position: Senior Manager Regulatory Affairs at Pfizer. Experienced in working on the compilation and review of CMC sections for electronic submissions of ANDAs for pharmaceutical clients. RAC certified. Previously, served as a founding member of a small product development/consulting company for 15 years. As co-founder, I was responsible for regulatory submissions using the eCTD format, such submissions include: ANDAs, Annual reports, Supplements, and Amendments, thus I am very familiar with the current FDA requirements for making electronic submissions. Concurrently, I ran the analytical and microbiological testing laboratory within the company. I am very proficient in all the Quality Control aspects of the Pharmaceutical Industry, and I am well-versed in the documentation required for the CMC portions of submissions. As a result of consulting for various clienteles, I have acquired diverse, in-depth, experience in the Pharmaceutical Industry in the areas of Quality Assurance, Quality Control, Regulatory Affairs and Product Development.

Banu Ramachandran

Current Position: Senior Manager Regulatory Affairs at Pfizer. Experienced in working on the compi...
Flemington, Flemington, United States

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Senior Manager Regulatory Affairs

Present

Director Of Regulatory Affairs

2013-11-01 00:00:00 - 2017-03-01 00:00:00

Independent Consultant, Rac Certified

2011-09-01 00:00:00 - 2013-11-01 00:00:00

Manager Of Regulatory Affairs And Laboratories

1996-12-01 00:00:00 - 2011-09-01 00:00:00

Project Coordinator / Principal Microbiologist

1995-09-01 00:00:00 - 1996-10-01 00:00:00

Senior Scientist

1988-10-01 00:00:00 - 1995-09-01 00:00:00

Post-Doctoral Fellow

1987-02-01 00:00:00 - 1988-09-01 00:00:00

No Skills Available

No Languages Available

Banu Ramachandran is a Current Position: Senior Manager Regulatory Affairs at Pfizer. Experienced in working on the compilation and review of CMC sections for electronic submissions of ANDAs for pharmaceutical clients. RAC certified. Previously, served as a founding member of a small product development/consulting company for 15 years. As co-founder, I was responsible for regulatory submissions using the eCTD format, such submissions include: ANDAs, Annual reports, Supplements, and Amendments, thus I am very familiar with the current FDA requirements for making electronic submissions. Concurrently, I ran the analytical and microbiological testing laboratory within the company. I am very proficient in all the Quality Control aspects of the Pharmaceutical Industry, and I am well-versed in the documentation required for the CMC portions of submissions. As a result of consulting for various clienteles, I have acquired diverse, in-depth, experience in the Pharmaceutical Industry in the areas of Quality Assurance, Quality Control, Regulatory Affairs and Product Development.

Banu Ramachandran has prior
experience in the following industries:
Citron Pharma | Self Employed | Pharmax | Sidmak Laboratories | The Childrens Hospital Of Philadelphia | Umdnj

Banu Ramachandran has the following professional experience:
Pfizer | Citron Pharma | Self Employed | Pharmax | Sidmak Laboratories | The Childrens Hospital Of Philadelphia | Umdnj