Smita Bulchandani
Senior Manager, Regulatory Affairs Development Strategy at Reata Pharmaceuticals, Inc.- Claim this Profile
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Bio
Peter Jons
Smita worked for me from 2014-2018 and had a significant positive impact to the business throughout that time. Tenacious, confident, with a meticulous attention to detail, Smita possesses a strong work ethic, has a creative and inquisitive mind, and always seeks to broaden her skills and knowledge. Smita is the consummate tram player and never shies away from helping a friend or colleague in need.
Niclas Lind
Smita has 7 years of experience within AZ GRO and started as a Dossier Manager in January 2019 and have done an excellent job during her time within the team. For the last 6 months she has been on a secondment as an RPM in Oncology to even more expand her knowledge in the Regulatory area. Smita has a ‘just do it’ mindset and never hesitates to take on new challenges. She always shows a willingness to go the extra mile, even during peak periods of work. She regularly contributes with ideas and insights to team and project teams, sharing best practice and new ways of doing things. Her experience and expertise from publishing work is highly valued and a good asset to the Dossier Manager team and she is always approachable for questions from the teams. She has also done significant efforts to expand her knowledge and therefore able to make highly-informed decisions. Smita is highly appreciated by her colleagues and team members, reliable and provide a stability to the team that is very important and she is always supportive and always willing to back up colleagues when needed. She is extremely process minded and has giving input to processes with accuracy, supporting colleagues and Project Teams with solutions and referring them to correct processes for compliance. Smita is very outgoing, proactive, detail focused, a good communicator and confident in her profession. She has strong work ethics and demonstrates ownership, responsibility and have a great sense of integrity. I am proud to have had Smita in my team as a real team player, always happy to help and never afraid to have an opinion. I would personally like to wish Smita the best of success in all future endeavors.
Peter Jons
Smita worked for me from 2014-2018 and had a significant positive impact to the business throughout that time. Tenacious, confident, with a meticulous attention to detail, Smita possesses a strong work ethic, has a creative and inquisitive mind, and always seeks to broaden her skills and knowledge. Smita is the consummate tram player and never shies away from helping a friend or colleague in need.
Niclas Lind
Smita has 7 years of experience within AZ GRO and started as a Dossier Manager in January 2019 and have done an excellent job during her time within the team. For the last 6 months she has been on a secondment as an RPM in Oncology to even more expand her knowledge in the Regulatory area. Smita has a ‘just do it’ mindset and never hesitates to take on new challenges. She always shows a willingness to go the extra mile, even during peak periods of work. She regularly contributes with ideas and insights to team and project teams, sharing best practice and new ways of doing things. Her experience and expertise from publishing work is highly valued and a good asset to the Dossier Manager team and she is always approachable for questions from the teams. She has also done significant efforts to expand her knowledge and therefore able to make highly-informed decisions. Smita is highly appreciated by her colleagues and team members, reliable and provide a stability to the team that is very important and she is always supportive and always willing to back up colleagues when needed. She is extremely process minded and has giving input to processes with accuracy, supporting colleagues and Project Teams with solutions and referring them to correct processes for compliance. Smita is very outgoing, proactive, detail focused, a good communicator and confident in her profession. She has strong work ethics and demonstrates ownership, responsibility and have a great sense of integrity. I am proud to have had Smita in my team as a real team player, always happy to help and never afraid to have an opinion. I would personally like to wish Smita the best of success in all future endeavors.
Peter Jons
Smita worked for me from 2014-2018 and had a significant positive impact to the business throughout that time. Tenacious, confident, with a meticulous attention to detail, Smita possesses a strong work ethic, has a creative and inquisitive mind, and always seeks to broaden her skills and knowledge. Smita is the consummate tram player and never shies away from helping a friend or colleague in need.
Niclas Lind
Smita has 7 years of experience within AZ GRO and started as a Dossier Manager in January 2019 and have done an excellent job during her time within the team. For the last 6 months she has been on a secondment as an RPM in Oncology to even more expand her knowledge in the Regulatory area. Smita has a ‘just do it’ mindset and never hesitates to take on new challenges. She always shows a willingness to go the extra mile, even during peak periods of work. She regularly contributes with ideas and insights to team and project teams, sharing best practice and new ways of doing things. Her experience and expertise from publishing work is highly valued and a good asset to the Dossier Manager team and she is always approachable for questions from the teams. She has also done significant efforts to expand her knowledge and therefore able to make highly-informed decisions. Smita is highly appreciated by her colleagues and team members, reliable and provide a stability to the team that is very important and she is always supportive and always willing to back up colleagues when needed. She is extremely process minded and has giving input to processes with accuracy, supporting colleagues and Project Teams with solutions and referring them to correct processes for compliance. Smita is very outgoing, proactive, detail focused, a good communicator and confident in her profession. She has strong work ethics and demonstrates ownership, responsibility and have a great sense of integrity. I am proud to have had Smita in my team as a real team player, always happy to help and never afraid to have an opinion. I would personally like to wish Smita the best of success in all future endeavors.
Peter Jons
Smita worked for me from 2014-2018 and had a significant positive impact to the business throughout that time. Tenacious, confident, with a meticulous attention to detail, Smita possesses a strong work ethic, has a creative and inquisitive mind, and always seeks to broaden her skills and knowledge. Smita is the consummate tram player and never shies away from helping a friend or colleague in need.
Niclas Lind
Smita has 7 years of experience within AZ GRO and started as a Dossier Manager in January 2019 and have done an excellent job during her time within the team. For the last 6 months she has been on a secondment as an RPM in Oncology to even more expand her knowledge in the Regulatory area. Smita has a ‘just do it’ mindset and never hesitates to take on new challenges. She always shows a willingness to go the extra mile, even during peak periods of work. She regularly contributes with ideas and insights to team and project teams, sharing best practice and new ways of doing things. Her experience and expertise from publishing work is highly valued and a good asset to the Dossier Manager team and she is always approachable for questions from the teams. She has also done significant efforts to expand her knowledge and therefore able to make highly-informed decisions. Smita is highly appreciated by her colleagues and team members, reliable and provide a stability to the team that is very important and she is always supportive and always willing to back up colleagues when needed. She is extremely process minded and has giving input to processes with accuracy, supporting colleagues and Project Teams with solutions and referring them to correct processes for compliance. Smita is very outgoing, proactive, detail focused, a good communicator and confident in her profession. She has strong work ethics and demonstrates ownership, responsibility and have a great sense of integrity. I am proud to have had Smita in my team as a real team player, always happy to help and never afraid to have an opinion. I would personally like to wish Smita the best of success in all future endeavors.
Credentials
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Overview: Clinical Pharmacology Considerations for Food Effect Studies
FDAJun, 2023- Nov, 2024 -
Microsoft Project 2019 and Project Online Desktop Essential Training
LinkedInJul, 2021- Nov, 2024 -
Smartsheet Essential Training
LinkedInJul, 2021- Nov, 2024 -
Communicating in the Language of Leadership
LinkedInMay, 2021- Nov, 2024 -
Effective Meeting Management
LinkedInMay, 2021- Nov, 2024 -
Project Management: Healthcare Projects
LinkedInApr, 2021- Nov, 2024 -
Prescription Drug Regulation, Cost, and Access: Current Controversies in Context
HarvardXJul, 2020- Nov, 2024 -
Applied Project Management
Wenell Management ABMay, 2020- Nov, 2024
Experience
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Reata Pharmaceuticals, Inc.
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United States
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Senior Manager, Regulatory Affairs Development Strategy
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Jul 2023 - Present
• Provided regulatory guidance necessary to support project development teams.• Responsible for managing the assembly of regulatory documents for review and submission to health authorities.• Worked closely with the Global Regulatory Leader, and helped develop global regulatory strategies to progress the development of Reata drugs• Supported execution of regulatory strategies including working closely with the Regulatory team and development teams to prepare regulatory plans (content plan and timeline) for the creation of document packages for regulatory submissions and management of document package preparation• Assisted in the preparation for meetings with global health authorities, and participated in the leadership of these meetings, as appropriate• Effectively coordinated with Regulatory Operations and Submission Management to ensure on-time preparation and publishing of regulatory submission documents• Identified and provided regulatory interpretation of regulations and guidance• Prepared information or responses as requested by regulatory agencies• Reviewed clinical protocols to ensure the collection of data needed to meet regulatory objectives and requirements• Ensured regulatory documentation is maintained appropriately• Along with a highly developed quality and entrepreneurial mindset, led collaborative efforts, strategic, and accountable, delivering results in an ethical and positive manner Show less
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Senior Manager Submissions Management
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Mar 2021 - Jul 2023
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AstraZeneca
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Project Manager
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Sep 2020 - Mar 2021
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Global Regulatory Operations Manager
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Jun 2014 - Mar 2021
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Taiho Pharmaceutical Co., Ltd.,
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Clinical Submission Manager
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Feb 2014 - Dec 2014
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IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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Jun 2013 - Feb 2014
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Hub Submission Manager
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Jun 2011 - Jun 2013
Worked directly with Clinical Development Operations, Global CMC Operations, Safety Surveillance, Pharmacologists and Strategists to ensure quality and consistency of data submitted as well as facilitated team review and resolved issues of published output to meet the deadlines Executed required dossier development build and publishing activities like creating bookmarks, hyperlinks(internal and external) within Submissions & Product licensing Support (S&PLS) Delivered project specific paper and electronic lifecycle managed submissions utilizing ISI ToolBox and eCTDXpress including co-ordination and execution of publishing solutions that meet unique requirements of IND, NDA and ANDA submissions, and management of product delivery to regulatory agencies. Prepared and submitted Amendments and Supplements (Labeling and CMC Amendments, Prior Approval Supplements, PADERs, CBE-30 and CBE-0) for NDAs and ANDAs along with clinical protocols, safety reports and annual reports for INDs Coordinated the preparation and quality control of regulatory applications and submissions in accordance with agency requirements. Understood and followed regulations, guidelines and procedures. Identified inconsistencies in routine and complex submissions. Adhered to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved Coordinated, managed and published major global submissions, including NDA, IND and DMF applications, using Pfizer’s eCTD System, , ISI Publisher, ViewPoint, GDMS, Adobe Acrobat and associated plug-ins. Show less
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StriVectin Operating Company
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United States
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Personal Care Product Manufacturing
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100 - 200 Employee
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Regulatory Affairs Associate
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Mar 2011 - Jun 2011
Keep current with the various international country submission/registration/approval and compliance requirements for marketing StriVectin products domestically and in 50+ countries outside the U.S.A. Maintain paper and electronic submission documents and databases in an accurate and timely manner Monitor pending and existing submissions/registrations to identify any unexpected delays; initiate re-registrations to avoid disruption in product availability by managing several dossiers Obtain export certificates from FDA and arrange for authentication of registration documents with state and federal authorities and foreign government embassies and consulates as required for registration process Show less
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Education
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Long Island University
Masters, Drug Regulatory Affairs -
Mumbai University Mumbai
Bachelor of Science - BS, Pharmaceutical Sciences