Ankita Rahate - Talawdekar
Mumbai
Summary
Highly accomplished regulatory affairs professional with over 10 years of experience in CMC submissions and regional regulatory strategies. Expertise in dossier preparation, regulatory compliance, and stakeholder management to drive successful product registrations across diverse global markets. Proven track record of navigating complex regulatory landscapes, and ensuring timely approvals.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Executive - Global Regulatory Affairs (CMC)
Glenmark Pharmaceuticals Ltd.
03.2024 - Current
- Dosage forms handled- Respiratory- Metered Dose Inhalers, Dry powder Inhalers, Nasal Sprays.
- Review CMC data, preparation of dossiers for Middle East, AFRICA, ASIA, Latin America countries.
- Arranging administrative documents viz. legal documents, samples, Working standards, artworks for filling.
- To ensure timely responding and closing of deficiencies received from country counterparts, consultants and MOH.
- Arranging documents for Site registration as per country requirements and submitting to country RA.
- Maintain LIVE status of CMC trackers- Fillings, approvals, deficiencies, site registrations.
- Maintain Medical request data sheet.
- To complete ASPIRE trainings on timely basis.
- To provide satisfactory regulatory support to stakeholders- Business development, Project management, R&D, Marketing, CQA, QA, Purchase, PDD etc.
- Presented on Technical topics- Inhalation products and Suppositories.
Senior Executive Regulatory Affairs
Meridian Enterprises Pvt. Ltd.
07.2021 - 03.2024
- Actively participated in Iphex 2023 for Meridian Enterprises Pvt. Ltd. at Hyderabad.
- Attended event 'Capacity Building Program on PHARMACEUTICAL QUALITY COMPLIANCE & FOREIGN TRADE -INDUSTRY PRACTICES & REGULATORY EXPECTATIONS' by Pharmexcil at ACG Auditorium Sci Tech Centre, Mumbai.
- Coordinate with internal and external stakeholders for regulatory dossiers related requirements- legals, artworks, samples.
- Review and compile CTD dossiers for African, GCC countries, ACTD dossiers for Asian countries and country specific dossiers for Latin American countries, CIS countries.
- Prepared registration dossiers and arranged re-registration requirements for following markets. Canada- OTC products.
- Africa- Zimbabwe, Zambia, Uganda, Ghana, DR Congo, Madagascar, Ethiopia, Malawi, Botswana.
- Latin America- Chile, Costa Rica, Dominican Republic, Guatemala.
- Asia-Myanmar, Nepal, Sri Lanka.
- CIS-Azerbaijan, Uzbekistan, Turkmenistan.
- GCC- UAE, Qatar, Kuwait, Bahrain.
- Interact with relevant regulatory authorities on a regular basis to complete process of obtaining registrations, initiating product renewals.
- Resolve queries raised by Ministries of respective countries.
- Interact with design team for artwork creation as per country requirements. Approve the shade cards of artworks for finalisation of commercial orders.
- Maintain the awareness of regulatory status and pending issues of all assigned products portfolio.
- Maintain detailed knowledge of different aspects of products -content of dossiers, regulatory timelines, regulatory strategies in the formats viz. Daily list, Weekly list, Monthly status report, Registration status.
- Maintain healthy team environment for smooth functioning of Regulatory activities.
- To check GAP analysis with EU guidelines.
Senior Executive Regulatory Affairs
Gopaldas Visram and Company Limited
12.2019 - 07.2021
- Preparation of CTD dossiers for African and country specific dossiers for Latam countries.
- Prepared registration dossiers for following markets. Africa- Tanzania, Nigeria, Uganda, Ghana, DR Congo, Kenya.
- Co-ordinating with the manufacturing plant for collection and review of documents viz. BMR, MFR, Process validation, stability, stability raw data, specifications, certificate of analysis.
- Application of legal documents viz. Product permission, Certificate of Pharmaceutical product, Free Sale Certificate. Maintaining a record of the legal documents.
- Arranging samples from plant for submission purpose to respective countries.
- Coordinating with design team for artwork creation as per country requirements.
- Involving in the discussions with the QA Head for formation of SOP's.
- Solving queries raised by respective countries.
Regulatory Affairs Executive
Indchemie Health Specialities Pvt. Ltd.
02.2017 - 12.2019
- Preparation of CTD, ACTD dossiers for new applications and renewal of applications for South East Asian and African countries.
- Preparation of dossiers of Multivitamin Supplements as per country specific guidelines.
- Updation of licensing and collecting information on registration instructions and regulations.
- Handled queries from Ministry of Health of Vietnam, Myanmar, Tanzania.
- Prepared registration dossiers for following markets. Africa- Tanzania, Zambia, Nigeria. South East Asia- Myanmar, Cambodia, Srilanka, Philippines.
Regulatory Affairs-Officer
Ciron Drugs and Pharmaceuticals Pvt. Ltd.
10.2014 - 02.2017
- Preparation and compilation of registration dossiers as per the guidelines and submission to regulatory authorities.
- Comprehensive knowledge and experience of CTD, ACTD, country specific and STD dossiers.
- Application, review, co-ordination, follow-up of legal documents COPP, WHO-GMP & FSC.
- Reviewing the technical documents such as process validation protocols and reports, stability studies, analytical method validation & Raw material, Finished product, Packing material specifications and COA's.
- Preparation and review of labeling and packaging material, package inserts.
- Dispatch of product samples and technical documents to clients.
- Solved technical queries of the dossiers.
- Prepared registration dossiers for following markets Africa- Uganda, Tanzania, Ethiopia, Latin America- Guatemala, Dominican Republic, Cuba.
Clinical Research Associate-Officer Grade
Ashco Niulabs Industries Pvt. Ltd.
05.2014 - 08.2014
- Preparation of the study integrated report and clinical report as per requirement, dosing of investigational product, preparation and verification of blood sample collection tube/vacutainer labels.
Medical Coder
GeBBS HEALTHCARE SOLUTIONS (Airoli)
06.2013 - 02.2014
- Analyzing whole given documentation to understand the patient's diagnosis assigned and procedures performed by physician and then as a Coder translating the physician's notes into medical codes by using ICD-9 diagnosis Codes, CPT procedure codes, using knowledge of Anatomy and physiology.
Education
Bachelor of Pharmacy -
Dr. L.H Hiranandani College of Pharmacy
Mumbai01.2013
H.S.C -
Holy Angels's Jr, College
Mumbai01.2009
S.S.C -
Vidya Niketan
Mumbai01.2007
Skills
- Regulatory compliance
- Dossier preparation
- CMC data review
- Site registration
- CTD compilation
Certification
PMP-PMI (Project Management Professional), Simplilearn
Awards
- Won prizes in table tennis, drawing competitions.
- Passed in Elementary examination with 'B' grade.
Hobbies and Interests
- Painting
- Calligraphy
Disclaimer
I hereby declare that all the information mentioned above is true to the best of my knowledge.
Languages
- English
- Hindi
- Marathi
Personal Information
- Date of Birth: 12/18/91
- Gender: Female
- Marital Status: Married
Additional Qualification
Post Graduate Diploma- Global Regulatory Affairs, Learned software for eCTD. Well versed with ICH guidelines.
Timeline
Executive - Global Regulatory Affairs (CMC)
Glenmark Pharmaceuticals Ltd.
03.2024 - Current
Senior Executive Regulatory Affairs
Meridian Enterprises Pvt. Ltd.
07.2021 - 03.2024
Senior Executive Regulatory Affairs
Gopaldas Visram and Company Limited
12.2019 - 07.2021
Regulatory Affairs Executive
Indchemie Health Specialities Pvt. Ltd.
02.2017 - 12.2019
Regulatory Affairs-Officer
Ciron Drugs and Pharmaceuticals Pvt. Ltd.
10.2014 - 02.2017
Clinical Research Associate-Officer Grade
Ashco Niulabs Industries Pvt. Ltd.
05.2014 - 08.2014
Medical Coder
GeBBS HEALTHCARE SOLUTIONS (Airoli)
06.2013 - 02.2014
Bachelor of Pharmacy -
Dr. L.H Hiranandani College of Pharmacy
H.S.C -
Holy Angels's Jr, College
S.S.C -
Vidya Niketan