President Golden State Regulatory Consulting LLC

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https://www.linkedin.com/in/kumara-sekar-8901647/ adn9fb@r.postjobfree.com Kumara S. Sekar, M.S., Ph.D.

Vice President, Global Head of Regulatory Affairs

Purpose-Driven Regulatory Affairs Leader with the Ability to Influence and Drive Strategy to Enable Regulatory Approval of Innovative and Generic Medicines.

Health Care Regulatory Affairs Executive with deep expertise in driving drug development strategy and execution by providing strategic input as well as guidance on technical and scientific issues during product development and submission. Talent for forging partnerships with key internal stakeholders and external leaders in government, academia and pharma. PROFESSIONAL EXPERIENCE

President, Golden State Regulatory Consulting, LLC. November 2020 – Present

• Regulatory, Compliance and Scientific consulting for small Pharmaceutical Companies

• Strategic partner to assist with product selection, CMO/CRO selection, compile and review filings to FDA.

• Audits of API, finished dosage and excipient facilities and support cGxP programs.

• Provide support to investors and virtual companies with drug development and US Regulatory landscape Vice President, Global Head of Regulatory Affairs July 2018- October 2020 Nanjing Noratech Pharmaceuticals, HBT Laboratories, Inc. TWi Pharmaceuticals

• Pre-IND meeting with Psychiatry division – preparation, review and submission of Briefing Book; conduct meeting with FDA to achieve successful clinical study design for first in man study

• EOP1 meeting to discuss clinical end points for pivotal clinical study, food effect study, finalizing CMC for product and conclusion of non-clinical development program

• Discussion with Psychiatry division on end points for pivotal clinical study and special protocol assessment.

• Discuss clinical hold due to revision of Key starting material and revision of synthetic route to remove clinical hold for Phase 1 study.

• Worked on several sNDA submissions for change of manufacturing site, changes in API and labeling changes President, KSS Consulting Inc. August 2015 to July 2018

• Regulatory and Scientific consultant for Pharmaceutical Companies.

• Advise companies and individuals regarding 505(b)(2) NDA, ANDA and OTC filings.

• Strategic partner to assist with product selection, CMO/CRO selection, compile and review filings to FDA.

• Perform audits of finished dosage to excipient facilities and assist with cGxP activities

• Liaison between companies and investors as consultant to file products to the FDA. Vice President, Regulatory Affairs, Micro Labs USA, Inc. June 2011 to July 2018

• Discuss and achieve best possible manufacturing process and related specifications for numerous products that were filed with the Office of Generic Drugs.

• Filing more than 70 ANDA submissions and primary liaison for addressing all Complete Response Letters to achieve shortest timeline for approval.

• Filing of 505(b)(2) NDA’s for anti-viral products Head of Regulatory for Dr. Reddy’s Laboratories Inc., Dr. Reddy’s Laboratories, LLC., Shreveport, Louisiana, and Promius Pharma, LLC, Specialty Pharmaceutical Company and Member of Senior Management Team for North America Generics March 2005 to July 2011

• Pre-IND package preparation and submissions to Dermatology Division for onychomychosis and dermatitis

• Prepare and conduct pre-IND meetings with Dermatology Division for several development products.

• Member of Crisis Management team to advise management on regulatory implications of crisis resolution strategies and on alerts/notifications/recalls for marketed products Global Regulatory Coordinator/Liaison, Aventis Pharmaceuticals, Inc. 2003 to 2005

• Prepare and submit sNDA for Opticlik Insulin pen for short acting and long acting insulin

• Maintain post approval activities for Lantus and Apidra insulin products

• Post approval activities for Amaryl, Avandamet

Senior Bioanalytical Scientist, Otsuka America Pharmaceuticals, Inc. 1997 to 2003 Research Scientist, Commonwealth Biotechnologies, Inc. 1992 to 1997 Adjunct Faculty, Department of Chemistry, Longwood College, Farmville, Virginia 1992 Graduate Teaching Assistant, Dept. of Chemistry, Virginia Commonwealth University 1987-1992 EDUCATION

Ph. D., Organic Chemistry, Virginia Commonwealth University, Richmond, VA M.S., Chemistry, University of Madras, Madras, India B.S., Chemistry, University of Madras, Madras, India PROFESSIONAL AFFILIATIONS

Regulatory Affairs Professional Society

Drug Information Association

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