PharmaReady
Kajal Jadav
Regulatory Affairs
Ahmedabad
Summary
To work with diligence and commitment in a challenging environment, where formal education and knowledge will always be utilized in different areas of interest. Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Overview
6
6
years of professional experience
3
3
Languages
Work History
Executive – Regulatory Affairs
Torrent Research Center
3 2024 - Current
- CMC submission for regulated markets (USA, Europe) and ROW markets (ASEAN, African and LATAM region)
- eCTD publishing and submission via electronic submission gateway
- Developed training materials for new hires, facilitating knowledge transfer and enhancing overall team competency in regulatory affairs.
- Attend change control meetings, review relevant documents and gather necessary information for CMC regulatory strategies
- Closely collaborate with project team members and affiliates to identify and quickly address any difficulties or queries raised by health authorities.
- Assessment of change controls for post approval activities
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
Executive – Regulatory Affairs
Medwise Overseas Pvt. Ltd
10.2022 - 02.2024
- End-to-end regulatory life cycle management of oral Dosage form
- Compilation of Registration, Re-registration dossiers as per CTD, ACTD and Country specific Guidelines for ROW markets
- Post-approval regulatory life cycle management of finished formulations for semi-regulated markets and ROW markets (ASEAN, African, and LATAM region)
- CMC dossier review Co-ordination and alignment with the cross functions and affiliates across the globe to obtain strategic regulatory intelligence
- Regulatory strategy formation and execution to acquire faster approvals, commercial launches and product life cycle management to ensure timely quality deliverables
- Review Technical documents of Third Party & co-ordinate with them
- Assisted in developing effective strategies for addressing FDA inquiries, leading to faster resolution times.
- Review and prepare technical documents for post approval changes (Variation Filling) Interacting with various cross-functional teams like QA, CMC, labelling and Publishing team for required documents
- Consulting regional requirements on application and maintenance of product permission, COPP, FSC and GMP certificate along with WHO GMP list
- Coordination with various plant’s QA, QC, R&D department for documentation pertaining to registrations procedures
- Artwork approval for new registration
- Independently drive projects & get the registration.
- Prepared comprehensive reports on the status of ongoing regulatory projects for management review and decision-making purposes.
Senior Officer – Quality Assurance
Unison Pharmaceuticals Pvt. Ltd.
03.2022 - 10.2022
- To Participate in APQR Activities and review of relevant documents like BMR, BPR, COA, MSDS, CAPA, Change control note, Stability data etc
- To review Hold time study data and report
- Review and approve Audit Trial
- Review and approve daily and monthly Stability data record
- Review and approve worksheets and logbook
- Participate in root cause analysis and incident report.
Senior Officer – Corporate Quality Assurance
Finecure Pharmaceuticals Limited.
12.2018 - 02.2022
- To review and verify dossier and regulatory related documents
- Solve customer as well as regulatory queries of various countries
- Prepare and apply product’s marketing authorization, licenses and other documents (Product Permission, COPP, Free Sale Certificate, NSQ, Market Standing Certificate etc.,) required for exporting the Products
- Prepare and review checklists and reports for audit and participate in internal and regulatory audit
- Prepare and review food and drug product information & SMPC to be reflected in the patient information leaflet and other labeling materials
- Provided reliable and accurate information and coordination with Business Development Group, Research & Development, Quality Control, Quality Assurance and other department in the organization when consulted regarding regulatory requirements, policy and guidelines
- To co-ordinate with production department and also prepare and review the documents required for Product development
- Development and review of packing materials and Mock-ups as per labeling guidelines of various countries
- New product Brand approval and trademark review
- Reviewed RDA and Nutritional Information for products under FSSAI category
- Reviewed various documents (coated & uncoated tablet BMR, BPR, COA, RM-COA, MSDS, Worksheet, DMF, Stability Data) To Prepare and review SOP.
Assistant Professor - Department of Pharmaceutical analysis and chemistry
Shree Swaminarayan Sanskar Pharmacy College.
08.2018 - 12.2018
Education
M.PHARM - QUALITY ASSURANCE AND REGULATORY AFFAIRS -
B.K. Modi Govt. Pharmacy College
B. PHARM - undefined
Shree Swaminarayan Sanskar Pharmacy College
Zundal, AhmedabadSkills
- Digital Skills: MS Office, Excel, Power point, Adobe Acrobat,Lab Solution and Empower Software
Skills Abilities
Analytical Procedure Validation, Regulatory documentations, Quality System, M.S. Office, Excel, Power point, Adobe Acrobat PDF, Lab Solution, Empower Software, PharmaReady, Trackwise, SharePoint, English, Hindi, Gujarati, Very good communicator and able to make the most of an international exposure, Ability to work either independently or in a team, Extremely self-motivated, confident and problem-solving, Ability to interpret and extract data from complex legal documents, Ability to plan and prioritize to meet aggressive processing deadlines
Project Training
Piramal Pharma Solutions, 7 Months, Stability Indicating Analytical Method Development and Validation of Eltrombopag Olamine using UPLC, Ahmedabad
Personal Information
- Date of Birth: 09/17/95
- Gender: Female
- Marital Status: Single
Software
Trackwise
Timeline
Executive – Regulatory Affairs
Medwise Overseas Pvt. Ltd
10.2022 - 02.2024
Senior Officer – Quality Assurance
Unison Pharmaceuticals Pvt. Ltd.
03.2022 - 10.2022
Senior Officer – Corporate Quality Assurance
Finecure Pharmaceuticals Limited.
12.2018 - 02.2022
Assistant Professor - Department of Pharmaceutical analysis and chemistry
Shree Swaminarayan Sanskar Pharmacy College.
08.2018 - 12.2018
Executive – Regulatory Affairs
Torrent Research Center
3 2024 - Current
M.PHARM - QUALITY ASSURANCE AND REGULATORY AFFAIRS -
B.K. Modi Govt. Pharmacy College
B. PHARM - undefined
Shree Swaminarayan Sanskar Pharmacy College
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