seasoned regulatory affairs professional with +18 years experience for drug registration in drug products for apac cis latam usfda african & eu countries@ SUZHOU MDCE CO., LTD
Bombay, Maharashtra, India
Archana Khade
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FlashIntel GPTArchana Khade is an experienced professional with 18.6 years of work experience in regulatory affairs and the pharmaceutical industry. She has expertise in SOAP, RIA, and regulatory submissions. Currently, she is working on a project with Russia to conduct clinical trials and drug product registration. Archana has also worked on various projects, including regulatory submissions and plant inspection for CIS. She has worked in countries such as Russia, CIS, Africa, Latin Ameria, and Asean countries. Her skills include regulatory submissions, plant inspection, and document preparation for pre-qualification and Re-registration.
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Total 11+ years of Experience in International Regulatory Affairs in Pharmaceutical Products, APIs viz Tablets, Capsules, , Topical Preparations, Inhalers etc. Currently working on Oncology Project with Russia for Conducting clinical Trials and drug product registration. Regulated, Semi-regulated and ROW markets submission. CMC part of Module 3 in CTD Dossier. Variation filling in WHO PEPFAR Projects. CTD, ACTD registration, almost all ROW markets dossier preparation. Plant inspection for CIS in Regulatory Perspective. Working on Biological products along with pharmaceuticals. Product Registration in Russia, CIS, Africa, Latin Ameria, Asean countries. International and Domestic Tender documents preparation. Documentation required for Pre-qualification, Re-registration
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seasoned regulatory affairs professional with +18 years experience for drug registration in drug products for apac cis latam usfda african & eu countries
Archana Khade's Professional Milestones
- Clinical Ra (2016-04-01~): Provided accurate and timely medication recommendations, ensuring patient satisfaction for the organization.
- Senior Executive - Regulatory Affairs (2007-01-01~2008-01-01): Successfully streamlined regulatory processes, ensuring compliance and minimizing regulatory risks.
Education
Pharmacy,
Bachelors,
Bachelor Of Pharmacy
2000-2004Skill
Regulatory Affairs
Sop
Pharmaceutical Industry
Anda
Regulatory Submissions
Ectd
Gmp
Generic Programming
Pharmaceutics
Pharmacovigilance
Regulatory Requirements
Query Handling
Dossier Submission
Document Review
Dossier Preparation
Glp
Fda
Validation
Clinical Trials
Quality Assurance
Standard Operating Procedure
Clinical Regulatory Affairs
U.s. Food And Drug Administration
Abbreviated New Drug Application
Good Laboratory Practice
Technology Transfer
Oncology
Biotechnology
Electronic Common Technical Document
Life Sciences
Medical Devices
Management
Formulation
Good Clinical Practice
Certification
Colleagues
Other Named Archana Khade
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Archana Khade works for SUZHOU MDCE CO., LTD
Archana Khade's role in SUZHOU MDCE CO., LTD is seasoned regulatory affairs professional with +18 years experience for drug registration in drug products for apac cis latam usfda african & eu countries
Archana Khade's colleagues are Joice Udechi,Dmitry Luchinin, MD, PhD
Archana Khade's latest job experience is seasoned regulatory affairs professional with +18 years experience for drug registration in drug products for apac cis latam usfda african & eu countries at SUZHOU MDCE CO., LTD
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