Rac Akhila Parthasarthy Email & Phone Number | • Comprehensive knowledge of development of small molecules, biopharmaceuticals, gene therapy and their regulatory requirements specifically for Chemistry, manufacturing and controls (CMC). • Good understanding of US FDA, ICH, Canadian and EU guidelines required for strategizing investigational and marketing applications pertaining to small molecules, biologics, gene therapies and medical devices. Proficient in preparing Health Agency meetings and interactions with different agencies. • Experienced in regulatory applications for gene therapy products at early stages and late stages (BLA/MAA). Proficient with preparation and review of Module 2 and 3 of regulatory submissions in CTD format. Extensive experience is redacting tier 1 dossiers to develop the International Core File (ICF) for submission in ROW (tier 2) countries. • Experienced with marketing applications in major markets (US, Canada, EU, Australia, Switzerland) and the rest of the world markets (LATAM, APAC, China, Japan, Israel). • Preparing efficient and streamlined regulatory strategies based on the requirement of each market to ensure quicker and faster approvals with fewer questions. • Experienced with post-marketing supplements and strategies for NDA and BLAs. Proficient in analyzing and assessing change controls. • Experience in preparing successful filings for combination products and well versed with device regulations and requirements for filing • Ph.D. in Biochemistry and an experienced Research Scientist in Oncology. Regulatory Affairs certification (RAC) from the Regulatory Affairs Professional Society (RAPS). • Excellent communication, interpersonal skills and strong leadership initiatives. Extensive knowledge of core sciences: - Molecular biology and Biochemistry - Analytical methods - Oncology - Neuroscience.

Rac Akhila Parthasarthy

• Comprehensive knowledge of development of small molecules, biopharmaceuticals, gene therapy and th...
Greater Boston, Greater Boston, United States

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Rac Akhila Parthasarthy’s Email aparthasarthy@ptcbio.com

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Rac Akhila Parthasarthy’s Location Greater Boston, Greater Boston, United States

Rac Akhila Parthasarthy’s Current Industry Editas Medicine

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Work Experience

Editas Medicine

Senior Director Regulatory CMC

2024-04-01 00:00:00 - Present

Ptc Therapeutics

Senior Director Regulatory CMC

2022-08-01 00:00:00 - 2024-04-01 00:00:00

Takeda

Regulatory CMC Lead

2018-06-01 00:00:00 - 2019-08-01 00:00:00

Shire

Regulatory CMC Lead

2015-12-01 00:00:00 - 2018-06-01 00:00:00

Synerg Pharma

Regulatory Consultant

2014-04-01 00:00:00 - 2015-11-01 00:00:00

Dana Farber Cancer Institute

Independent Investigator

2010-02-01 00:00:00 - 2011-01-01 00:00:00

Dana Farber Cancer Institute And Harvard Medical School

Research Scientist

2006-09-01 00:00:00 - 2010-01-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Rac Akhila Parthasarthy

Rac Akhila Parthasarthy is located at
Greater Boston, Greater Boston, United States

Rac Akhila Parthasarthy is a • Comprehensive knowledge of development of small molecules, biopharmaceuticals, gene therapy and their regulatory requirements specifically for Chemistry, manufacturing and controls (CMC). • Good understanding of US FDA, ICH, Canadian and EU guidelines required for strategizing investigational and marketing applications pertaining to small molecules, biologics, gene therapies and medical devices. Proficient in preparing Health Agency meetings and interactions with different agencies. • Experienced in regulatory applications for gene therapy products at early stages and late stages (BLA/MAA). Proficient with preparation and review of Module 2 and 3 of regulatory submissions in CTD format. Extensive experience is redacting tier 1 dossiers to develop the International Core File (ICF) for submission in ROW (tier 2) countries. • Experienced with marketing applications in major markets (US, Canada, EU, Australia, Switzerland) and the rest of the world markets (LATAM, APAC, China, Japan, Israel). • Preparing efficient and streamlined regulatory strategies based on the requirement of each market to ensure quicker and faster approvals with fewer questions. • Experienced with post-marketing supplements and strategies for NDA and BLAs. Proficient in analyzing and assessing change controls. • Experience in preparing successful filings for combination products and well versed with device regulations and requirements for filing • Ph.D. in Biochemistry and an experienced Research Scientist in Oncology. Regulatory Affairs certification (RAC) from the Regulatory Affairs Professional Society (RAPS). • Excellent communication, interpersonal skills and strong leadership initiatives. Extensive knowledge of core sciences: - Molecular biology and Biochemistry - Analytical methods - Oncology - Neuroscience. - Immunology.

Rac Akhila Parthasarthy currently works in the Editas Medicine |

No Languages Available

Rac Akhila Parthasarthy has prior
experience in the following industries:
Ptc Therapeutics | Takeda | Shire | Synerg Pharma | Dana Farber Cancer Institute | Dana Farber Cancer Institute And Harvard Medical School

Rac Akhila Parthasarthy has the following professional experience:
Editas Medicine | Ptc Therapeutics | Takeda | Shire | Synerg Pharma | Dana Farber Cancer Institute | Dana Farber Cancer Institute And Harvard Medical School