Meghna Punjabi Thakkar
Regulatory Officer at B Medical Systems- Claim this Profile
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Bio
Santhosh Kumar
Meghna has a tremendous skill in regulatory guidelines of pharmaceuticals and has set her own benchmark of standard in every regulatory team and projects she worked. She is very good at decision making during critical times, she accepts challenges and always stays optimistic towards achieving organizational goals. She has tremendous insights in analysing things. I recommend Meghna to any position and all my best wishes to all the great, responsible work that she does.
Sandeep Madhurao
When I met Meghna during her interview in 2019, the very first impression I had was that she was highly energetic and confident. She brings in a wealth of knowledge in the field of Regulatory Affairs and has a contagious ‘can-do’ attitude. She was instrumental in transition of a new process from the client. Her ability to plan and handle high workload is unmatched, she goes above and beyond her responsibilities to ensure that task is completed within agreed timelines. She consistently demonstrated High-Performance Culture. She was a person whom the management trusted and her peers look upon for guidance and support. It is my privilege to recommend her and have within my professional network.
Santhosh Kumar
Meghna has a tremendous skill in regulatory guidelines of pharmaceuticals and has set her own benchmark of standard in every regulatory team and projects she worked. She is very good at decision making during critical times, she accepts challenges and always stays optimistic towards achieving organizational goals. She has tremendous insights in analysing things. I recommend Meghna to any position and all my best wishes to all the great, responsible work that she does.
Sandeep Madhurao
When I met Meghna during her interview in 2019, the very first impression I had was that she was highly energetic and confident. She brings in a wealth of knowledge in the field of Regulatory Affairs and has a contagious ‘can-do’ attitude. She was instrumental in transition of a new process from the client. Her ability to plan and handle high workload is unmatched, she goes above and beyond her responsibilities to ensure that task is completed within agreed timelines. She consistently demonstrated High-Performance Culture. She was a person whom the management trusted and her peers look upon for guidance and support. It is my privilege to recommend her and have within my professional network.
Santhosh Kumar
Meghna has a tremendous skill in regulatory guidelines of pharmaceuticals and has set her own benchmark of standard in every regulatory team and projects she worked. She is very good at decision making during critical times, she accepts challenges and always stays optimistic towards achieving organizational goals. She has tremendous insights in analysing things. I recommend Meghna to any position and all my best wishes to all the great, responsible work that she does.
Sandeep Madhurao
When I met Meghna during her interview in 2019, the very first impression I had was that she was highly energetic and confident. She brings in a wealth of knowledge in the field of Regulatory Affairs and has a contagious ‘can-do’ attitude. She was instrumental in transition of a new process from the client. Her ability to plan and handle high workload is unmatched, she goes above and beyond her responsibilities to ensure that task is completed within agreed timelines. She consistently demonstrated High-Performance Culture. She was a person whom the management trusted and her peers look upon for guidance and support. It is my privilege to recommend her and have within my professional network.
Santhosh Kumar
Meghna has a tremendous skill in regulatory guidelines of pharmaceuticals and has set her own benchmark of standard in every regulatory team and projects she worked. She is very good at decision making during critical times, she accepts challenges and always stays optimistic towards achieving organizational goals. She has tremendous insights in analysing things. I recommend Meghna to any position and all my best wishes to all the great, responsible work that she does.
Sandeep Madhurao
When I met Meghna during her interview in 2019, the very first impression I had was that she was highly energetic and confident. She brings in a wealth of knowledge in the field of Regulatory Affairs and has a contagious ‘can-do’ attitude. She was instrumental in transition of a new process from the client. Her ability to plan and handle high workload is unmatched, she goes above and beyond her responsibilities to ensure that task is completed within agreed timelines. She consistently demonstrated High-Performance Culture. She was a person whom the management trusted and her peers look upon for guidance and support. It is my privilege to recommend her and have within my professional network.
Experience
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B Medical Systems
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Luxembourg
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory Officer
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Aug 2021 - Present
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International Dual Career Network (IDCN)
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Switzerland
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Non-profit Organizations
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1 - 100 Employee
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Event Coordinator
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Apr 2021 - Aug 2021
Events coordinator: Role: Organize networking events, webinars, mingle hours as well as Corporate Member Events. IDCN helps to facilitate networking, information and peer-to-peer learning for members to restart their careers after moving to Luxembourg. Events coordinator: Role: Organize networking events, webinars, mingle hours as well as Corporate Member Events. IDCN helps to facilitate networking, information and peer-to-peer learning for members to restart their careers after moving to Luxembourg.
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PAREXEL International (India) Private Ltd
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700 & Above Employee
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Senior Regulatory Affairs Associate
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Nov 2019 - Mar 2021
Dossier manager for MRP/DCP and vaccines worksharing submissions (Client: Sanofi, Sanofi pasteur) Role: -Lead the team for 2 projects: MRP/DCP pharmaceutical submissions and Vaccines worksharing submissions. -Quality review of lifecycle for CP, MRP, DCP and national procedures, renewals, PSUSA, PSUR submissions in eCTD formats -Submit the dossiers and obtain the approvals from health authorities -Respond to queries/requests received from the Authorities/external partners regarding the submitted dossier -Update the internal systems with the submission date/approval date -Work closely with the client to deliver day to day regulatory submissions with high quality and timelines Additional: Imparting regular trainings to team Show less
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Naprod Life Sciences Pvt. Ltd.
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India
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Associate
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Oct 2018 - Mar 2019
Senior Associate - New Product Development - Project management Role : - Collect and evaluate the data which will be included in the authorization dossier for EU and International market - Prepare the support documentation for variations submission - Respond to requests received from the Authorities/external partners regarding the dossier - Prepare the documentation for renewal of Marketing Authorization - Evaluate the deficiency letter and collaborate with all the involved departments (R&D, Quality Control, Quality Assurance, Production) for getting the best answers - Review and finalise the artwork with respect to guidelines with packaging devllopment. Additional : - Development of various executive presentations and reports to facilitate the project evaluation and process improvement. - Supporting business development and plant for new product development. - Review of documents and submission to customer. Show less
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Cipla
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Executive
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Sep 2014 - Oct 2018
Senior Executive in Regulatory Affairs and Quality Assurance : Role: - Preparation of the consolidated dossiers for the Filings (Europe, US and International market) - Collect and evaluate the quality data (Module 2 and Module 3) which will be included in the authorization dossier - Preparation of documents for CMC variations submission: Life cycle management and post authorisation maintenance (post approval commitments) - Evaluation, raising and approval of changes with impact assessment for QA/RA - SPOC for responding to all regulatory deficiencies - Close tracking of Marketing authorizations - Review of annual reports - Coordination for license application and filing of certificate of pharmaceutical products - Review and upkeep of quality technical agreements Additional : Quality Management System: - To lead the quality improvement program for Cipla products as per global quality plan like execute APQR, implementation of continuous process verification, process capabilities and other quality excellence initiatives - Handling, investigating, reviewing, closing and trending of product quality complaints, responding to complainants, designing CAPA. - Responsible for review of phase II out of trend and out of specification - Team SPOC for Risk management (Failure, Mode Effects and Criticality analysis) - Experience of handling direct or indirect regulatory inspections viz USFDA, UKMHRA, TGA, MCC, WHO & consultants like Lachman & VanZyl GMP international. - Technology Transfer: Supporting R&D function for new product development and site transfer of the products at the site Show less
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M/s. Plethico Pharmaceuticals Ltd., Indore
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India
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Research Executive
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Jul 2013 - Aug 2014
An Executive in Analytical Development Laboratory Role: - Analytical method development and validation for Pharmaceutical dosage forms like Solid ( tablet, POS, Effervescent tab), Liquid ( Syrup, Suspension), Semi solid ( Gel, Cream). - Physio-chemical analysis of the finished product, raw materials and excipients, according to specifications and procedures, using the following techniques: HPLC (Agilent), Karl Fischer Titrator, GC (Agilent), potentiometric titration, UV-VIS Spectrophotometry - Calibrations of HPLC, UV Visible Spectrophotometer, Dissolution apparatus, and other lab instruments - Designing of Analytical Method Validation Protocols in accordance with respective guidelines - Data Entry and Review (Protocols, Instrument calibration and usage Records, Stability Studies) - Execute all laboratory activities, as per current GLP norms, and regulatory requirements Additional : Preparation of standard operating procedures and specifications Show less
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Education
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2013 - 2014
Global Institute of Regulatory Affairs
PG DIPLOMA in Regulatory Affairs, Pharmacy Administration and Pharmacy Policy and Regulatory Affairs -
2010 - 2012
University Institute of Technology, RGPV
Master's degree, Pharmacy -
2006 - 2010
University Institute of Technology, RGPV
Bachelor's degree, Pharmacy -
2004 - 2006
St. Mary's convent senior secondary school
Biology with computer science, CBSE -
Vindhyachal Academy
CBSE, Nursery to 10th, School
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