SANJAY K RANGADHOL
Vice President, R&D and Regulatory at Qualigens Pharma Private Limited- Claim this Profile
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Bio
Milind Sathe Founder Compulsory Licensing Group
Sanjay is a hardcore R&D leader with in-depth knowledge of regulatory guidelines that regulate generation, compilation and submission of development and validation data in dossier for regulatory approval. He is always updated with various databases and attributes of components which make a stable composition. He is an asset wherever he is associated with.
Suphadej Amnuaysakul
To Sanjay, We met you in Bangkok and got mesmerized by your understanding, knowledge, and willingness to share your knowledge...good luck to you.
LinkedIn User
It’s my absolute pleasure to recommend Sanjay . I know him personally since our stay at Ahmadabad at the beginning of year 2000. since then, we are in touch with each other its been 20+ years of acquaintance and its been a pleasure to write recommendation for future endeavors of his career. He is a truly valuable asset to absolutely any team. He is honest, dependable, and incredibly hard-working. Beyond that, he is an impressive skills in setting up of RnD and Process labs for Pharmaceutical development of generic products, His knowledge of parental preparations and expertise in tech transfer and headed several organization at various level and was always executed his duty and succeed to develop team as a leader and he would be a huge advantage to your entire organization. He put this skillset to work in order to achieve organizational growth.. Along with his undeniable talent, Sanjay has always been an absolute joy to work with. He is a true team player, and always manages to foster positive discussions and bring the best out of other employees. Without a doubt, I confidently recommend Sanjay. As a dedicated and knowledgeable employee and an all-around great person, I know that he will be a beneficial addition to any organization.
Milind Sathe Founder Compulsory Licensing Group
Sanjay is a hardcore R&D leader with in-depth knowledge of regulatory guidelines that regulate generation, compilation and submission of development and validation data in dossier for regulatory approval. He is always updated with various databases and attributes of components which make a stable composition. He is an asset wherever he is associated with.
Suphadej Amnuaysakul
To Sanjay, We met you in Bangkok and got mesmerized by your understanding, knowledge, and willingness to share your knowledge...good luck to you.
LinkedIn User
It’s my absolute pleasure to recommend Sanjay . I know him personally since our stay at Ahmadabad at the beginning of year 2000. since then, we are in touch with each other its been 20+ years of acquaintance and its been a pleasure to write recommendation for future endeavors of his career. He is a truly valuable asset to absolutely any team. He is honest, dependable, and incredibly hard-working. Beyond that, he is an impressive skills in setting up of RnD and Process labs for Pharmaceutical development of generic products, His knowledge of parental preparations and expertise in tech transfer and headed several organization at various level and was always executed his duty and succeed to develop team as a leader and he would be a huge advantage to your entire organization. He put this skillset to work in order to achieve organizational growth.. Along with his undeniable talent, Sanjay has always been an absolute joy to work with. He is a true team player, and always manages to foster positive discussions and bring the best out of other employees. Without a doubt, I confidently recommend Sanjay. As a dedicated and knowledgeable employee and an all-around great person, I know that he will be a beneficial addition to any organization.
Milind Sathe Founder Compulsory Licensing Group
Sanjay is a hardcore R&D leader with in-depth knowledge of regulatory guidelines that regulate generation, compilation and submission of development and validation data in dossier for regulatory approval. He is always updated with various databases and attributes of components which make a stable composition. He is an asset wherever he is associated with.
Suphadej Amnuaysakul
To Sanjay, We met you in Bangkok and got mesmerized by your understanding, knowledge, and willingness to share your knowledge...good luck to you.
LinkedIn User
It’s my absolute pleasure to recommend Sanjay . I know him personally since our stay at Ahmadabad at the beginning of year 2000. since then, we are in touch with each other its been 20+ years of acquaintance and its been a pleasure to write recommendation for future endeavors of his career. He is a truly valuable asset to absolutely any team. He is honest, dependable, and incredibly hard-working. Beyond that, he is an impressive skills in setting up of RnD and Process labs for Pharmaceutical development of generic products, His knowledge of parental preparations and expertise in tech transfer and headed several organization at various level and was always executed his duty and succeed to develop team as a leader and he would be a huge advantage to your entire organization. He put this skillset to work in order to achieve organizational growth.. Along with his undeniable talent, Sanjay has always been an absolute joy to work with. He is a true team player, and always manages to foster positive discussions and bring the best out of other employees. Without a doubt, I confidently recommend Sanjay. As a dedicated and knowledgeable employee and an all-around great person, I know that he will be a beneficial addition to any organization.
Milind Sathe Founder Compulsory Licensing Group
Sanjay is a hardcore R&D leader with in-depth knowledge of regulatory guidelines that regulate generation, compilation and submission of development and validation data in dossier for regulatory approval. He is always updated with various databases and attributes of components which make a stable composition. He is an asset wherever he is associated with.
Suphadej Amnuaysakul
To Sanjay, We met you in Bangkok and got mesmerized by your understanding, knowledge, and willingness to share your knowledge...good luck to you.
LinkedIn User
It’s my absolute pleasure to recommend Sanjay . I know him personally since our stay at Ahmadabad at the beginning of year 2000. since then, we are in touch with each other its been 20+ years of acquaintance and its been a pleasure to write recommendation for future endeavors of his career. He is a truly valuable asset to absolutely any team. He is honest, dependable, and incredibly hard-working. Beyond that, he is an impressive skills in setting up of RnD and Process labs for Pharmaceutical development of generic products, His knowledge of parental preparations and expertise in tech transfer and headed several organization at various level and was always executed his duty and succeed to develop team as a leader and he would be a huge advantage to your entire organization. He put this skillset to work in order to achieve organizational growth.. Along with his undeniable talent, Sanjay has always been an absolute joy to work with. He is a true team player, and always manages to foster positive discussions and bring the best out of other employees. Without a doubt, I confidently recommend Sanjay. As a dedicated and knowledgeable employee and an all-around great person, I know that he will be a beneficial addition to any organization.
Experience
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Qualigens Pharma Private Limited
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India
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Vice President, R&D and Regulatory
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Aug 2022 - Present
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Actigen Company Limited
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United Kingdom
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Biotechnology
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1 - 100 Employee
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Technical Director
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Nov 2018 - Jul 2022
▪ Completed set-up of Pharma product development center and leading the development of generic products for Thailand, EU & Asian markets. ▪ Playing an active role in the management and introduction of new products, including project planning and end-to-end product development. ▪ Monitor the development of robust, effective bioequivalent Pharma products meeting all regulatory requirements. Working on resource planning, allocation, completing the validation batches, BE studies, product registration and product launches. Show less
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Themis Medicare
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1 - 100 Employee
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Head of Research & Development
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Apr 2017 - Nov 2018
▪ Handled injectable product & process development of generics & super generics; including many an onco injectables. ▪ Literature & patent searches related to new products. ▪ Planned, resource allocation and execution of validation batches at production facility. ▪ Risk evaluation of process parameters, mitigate any possible risk via controlling the critical process parameters and critical material attributes. ▪ Trouble-shoot and improve on the existing manufacturing process. Answered technical queries of regulatory agencies and technical support to market complaints. Show less
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Director, Drug Development
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Mar 2008 - Mar 2016
+ Formulation development of the generic & exploratory drug product development through different regulatory stages - from idea to commercialization. + Serving as technical representative on cross-functional teams supporting products throughout the stages of development and product registration. + Recognizing and working closely with CMO’s for agreement, costing, material supplies, analytical method validations and tech transfer of R&D batches. + Leading technical transfer of approved products to external manufacturers and assembling all technical documents pertaining to product registration. + Ensuring the Quality (CMC) section of the submission documents is complete and consistent with applicable regulatory guidelines and requirements Show less
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Manager, Formulations
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Oct 2004 - Feb 2008
▪ Developed, robust and stable formulations of new products that complies with the requirements of marketing. Conducted Pre-formulation, Formulation, Packaging and Stability study for generic drug product developments for regulated markets. ▪ Monitored multi-project tasks assigned, from initial approval through to successful scale up and regulatory submission; and reported progress on a regular basis. ▪ Ensured completeness of optimization & validation batch protocols & reports. Identified and worked closely to execute PK/clinical studies. Reviewed and approved the study plan, agreements, protocols, monitored the studies and presented the data. Show less
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Ranbaxy
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Research Scientist - Process Development
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Jun 2003 - Oct 2004
▪ Process & product development of Tablets as well as Soft Gelatin Capsules; technology transfer of batches to shop floor and completing validation batches of Para IV, NDA & ANDA fillings. ▪ Worked with team to implement the regulatory strategy to move products through development and regulatory approvals ▪ Review of Master Batch Manufacturing and Packaging records, Validation protocols & reports. ▪ Compiled and reviewed documentation associated with regulatory submissions; supported regulatory inspections as and when required. Cross functional participation both within and outside the R&D for supporting product development, including analytical, clinical, bio-analytical, technology transfer, production, QC/QA and regulatory teams. Show less
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Banner Pharmacaps
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India
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Biotechnology Research
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Executive, Product Development & Regulatory Affairs
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Aug 2001 - Jun 2003
▪ Formulation and manufacturing of soft gelatin capsules and soflets (gelatin enrobed tablets) for UK and Australian markets. ▪ Worked on pilot plant scale up trials, technology transfer to shop floor, process optimization, process trouble shooting and process validation. ▪ Worked on OTC & nutraceutical products Reviewed documents like batch manufacturing records, stability protocols, validation protocols, validation reports and specifications like raw materials, packaging materials, in-process, finished product and shelf-life specifications for regulatory compliance. Show less
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Cadila Pharmaceuticals Limited
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Executive Regulatory
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Dec 2000 - Aug 2001
Technical dossier compilation of different dosage forms for product registrations with USFDA, MHRA, EMC, ASEAN regions. Coordinating with R&D, Manufacturing, QC and various regulatory agencies. Technical dossier compilation of different dosage forms for product registrations with USFDA, MHRA, EMC, ASEAN regions. Coordinating with R&D, Manufacturing, QC and various regulatory agencies.
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Education
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1996 - 1998
JSS University (Jagadguru Sri Shivarathreeshwara University),Mysore
Masters of Pharmacy, Industrial Pharmacy -
1990 - 1994
Kuvempu University, Shankaraghatta, Shimoga
Bachelors of Pharmacy, Pharmaceutical Sciences
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