Jaiprakash Bhelonde

Nonclinical/Toxicology Expert with more than 21 years of experience in regulatory toxicology, nonclinical writing and safety assessment of pharmaceuticals. An established leader with several years of experience in successfully leading complex programs through nonclinical development. Successfully leading nonclinical team of 20+ members and supporting diverse programs for several years. Key highlights of professional experience and expertise include: thorough knowledge and understanding of various regulatory guidelines, and familiarity with international best practices related to nonclinical development of pharmaceuticals. Extensive experience in drafting, reviewing, and compiling nonclinical regulatory documents for IND, NDA, MAA, and BLA submissions. Successfully leading complex projects as a preclinical subject matter expert including technical writing. Providing response/answers to regulatory queries pertaining to nonclinical/toxicological aspects of the submissions. Participation in business meetings as preclinical expert and presentation of technical capabilities including review of project proposals and commercials. Providing guidance and mentorship to junior colleagues including training and development to enhance their skills for effective writing/review of nonclinical technical documents. Regularly oversee the deliverables and provide appropriate feedback on the quality of documents. Identification, qualification and approval of CRO for conduct of GLP and non-GLP studies including monitoring of studies to ensure the integrity and quality of data. Designing, planning and overseeing the conduction of pharmacology, safety pharmacology and toxicology studies. (Q)SAR assessment and ICH M7-compliant expert review/reporting of genotoxicity evaluations of impurities and degradation products. Environmental risk assessments (ERAs) and monitoring of environmental studies to support ERA assessments. Planning and developing work-flows (work instructions), standard operating procedures and guidelines for departmental activities. Good knowledge and understanding of various regulatory guidelines, including ISO and GLP regulations and processes. Accomplished Deputy General Manager with strong experience in strategic planning, team management, and operational improvement. Known for excellent problem-solving skills and ability to lead high-performing teams. Proven track record of improving business processes and driving revenue growth through innovative strategies. Seasoned professional in general and operations management with comprehensive experience leading teams, optimizing processes, and implementing cost-effective strategies. Skilled in strategic planning, staff development, and operational efficiency, consistently improving workflow and reducing costs. Proven track record of enhancing overall business performance through effective leadership and innovative problem-solving.

• Society of Toxicologic Pathologists in India (STPI)
• Laboratory Animal Scientists Association (LASA) – India
• Indian Association of Veterinary Pathologist (IAVP)
• Indian College of Veterinary Pathologists (ICVP)
• Diplomate, American Board of Toxicology (ABT)

Regulatory Toxicology & Safety Evaluation: Planning and conduct of all kinds of nonclinical and toxicology studies including early discovery and regulatory/GLP type studies in accordance with various regulatory requirements., Successfully submitted several toxicology and safety studies to various international regulatory agencies viz. USFDA, EMA, MHRA and DCGI (India).

Strategic Services on Nonclinical Development: Provided strategic services including devising complete nonclinical development program and designing of appropriate nonclinical studies based on type of research program and regulatory requirements for US, EU and India., Effectively handled and answered regulatory queries related to nonclinical aspects., Provided sound scientific justifications/rationale for exceeding or higher levels of impurities, excipients., Provided strategic inputs and guidance on toxicology testing strategies including planning and designing of appropriate toxicology studies for qualification of impurities in drug substance/products., Providing justification/rationale for seeking waiver for specific nonclinical studies based on the typical program., Asking appropriate queries/questions related to nonclinical development to Agencies through pre-IND or Scientific Advice meetings., Successfully handled several regulatory queries including information requests (IRs) from various regulatory agencies including USFDA.

Writing and Review of Nonclinical Documents for Regulatory Submissions., Writing and review of pre-IND/NDA briefing books/packages including the writing/update of Investigator’s Brochure (IB)., Writing and review of nonclinical modules such as Module 2.4, 2.6 and 4., Review and gap analyses of nonclinical data and already drafted/written nonclinical documents., Special protocol assessment (SPA) briefing document and submission for carcinogenicity studies on pharmaceuticals., Writing of scientific rationale/justification in support of waiver for ‘Abuse Liability Assessment’ depending on the type of project/submission.

Health Based Exposure Limits (HBEL) - Preparation and review of HBELs for API [permitted daily exposure (PDE) or allowable daily exposure (ADE)] and Occupational Exposure Limits (OEL) for active pharmaceuticals, excipients, cleaning agents and other potential cross contaminants., Toxicological evaluation and assessment of genotoxic and non-genotoxic impurities by using QSAR tools and expert knowledge., Toxicological evaluation and assessment of extractables and leachables., Toxicological evaluation and assessment of elemental impurities., Toxicological evaluation and assessment of flavours and colouring agents.

Mrs. Vaishali J. Bhelonde, Jayant, Hemant

Date of Birth: 09/05/76

I hereby solemnly declare that the particulars given above in this CV are true and correct to the best of my knowledge and belief.

Experience of handling smaller to larger teams of about five (05) to twenty-six (26) members from diverse educational and cultural backgrounds including geographical locations. Successfully completed several simple and complex programs/projects with multidisciplinary teams., Lead and represent nonclinical/toxicology team at organizational level and in business meetings., Project management and handling client queries, feedback/complaints., Managing client relationships., Planning of annual CAPEX and revenue budgets., Effective communication and delegation of responsibilities., Planning, decision making, and problem solving., Understanding the team dynamics and encouraging good relationships., Recruitment, training, supervision, and appraisal of the staff/team members., Setting performance goals with company's plan and vision., Monitoring employee productivity and providing constructive feedback.

Nonclinical/Toxicology Expert with more than 21 years of experience in regulatory toxicology, nonclinical writing and safety assessment of pharmaceuticals. An established leader with several years of experience in successfully leading complex programs through nonclinical development. Successfully leading nonclinical team of 20+ members and supporting diverse programs for several years., Thorough knowledge and understanding of various regulatory guidelines and familiarity with international best practices related to nonclinical development of pharmaceuticals., Extensive experience in drafting, review and compilation of nonclinical regulatory documents for IND/NDA/MAA/BLA submissions., Successfully leading complex projects as a preclinical subject matter expert including technical writing., Providing response/answers to regulatory queries pertaining to nonclinical/toxicological aspects of the submissions., Participation in business meetings as preclinical expert and presentation of technical capabilities including review of project proposals and commercials., Providing guidance and mentorship to junior colleagues including training and development to enhance their skills for effective writing/review of nonclinical technical documents., Regularly oversee the deliverables and provide appropriate feedback on the quality of documents., Identification, qualification and approval of CRO for conduct of GLP and non-GLP studies including monitoring of studies to ensure the integrity and quality of data., Designing, planning and overseeing the conduction of pharmacology, safety pharmacology and toxicology studies., (Q)SAR assessment and ICH M7-compliant expert review/reporting of genotoxicity evaluations of impurities and degradation products., Environmental risk assessments (ERAs) and monitoring of environmental studies to support ERA assessments., Planning and developing work-flows (work instructions), standard operating procedures and guidelines for departmental activities., Good knowledge and understanding of various regulatory guidelines, including ISO and GLP regulations and processes.

• Received the ACE OF NEW INITIATIVE, the second highest organizational award for the initiation of toxicological risk assessment of impurities, extractables, and leachables at Fryer (2021-22)
• Received a HIGH FIVE, the highest divisional award for consistent performance and delivering a record number of 400+ HBEL reports in a year at Freyr (2021-22)
• Received the APPRECIATE (Applauding and Recognizing Individuals and Team Excellence) award for excellent teamwork in the R&D GLP test facility (2007-2008) at Ranbaxy Research Laboratories
• Received the APPRECIATE award for the successful completion and reporting of Segment I (as per Schedule Y and ICH guidelines) studies for NCE (RBx11160 maleate)

• Diplomate, American Board of Toxicology (DABT); 2012. Recertifications: 2017 & 2022
• Diplomate, Indian College of Veterinary Pathology (DICVP), Board certificate examination in Veterinary Pathology conducted by Indian College of Veterinary Pathologists (https://www.icvp.in); 2011