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NIDHI RONAK SHAH (Mpharm)
Mobile: 00968-98898292
Current Address Permanent Address
24 Oman solar building, 20 Bansidhar Appt, Dalal Colony
Oman pharmaceutical campus, Ramannagar
Azaiba, Seeb Maninagar
Muscat, OMAN Ahmedabad.
P.O. Box 1885
OBJECTIVE____________________________________________________________________
I am looking for a challenging career in field of Regulatory Affairs, which provides opportunities
to fulfill organizations goals with consistent quality and helps in self development.
EDUCATION___________________________________________________________________
M.Pharm (Pharmaceutics) (2009-2011) – Gujarat University – Parul Institute of pharmacy,
Vadodara
B.Pharm(final year - 2007) – Rajiv Gandhi University – Mangalore, Karnataka
H.S.C (2003) - Utkarsh vidyalaya Eng.Med, Vadodara- Gujarat Board
S.S.C (2001) - Utkarsh vidyalaya Eng.Med, Vadodara- Gujarat Board
ADDITIONAL QUALIFICATIONS_____________________________________________________
Regulatory Affairs (Distance learning 2010) - Bioinformatics Institute of India, Delhi
GMP (Distance learning 2009) - Bioinformatics Institute of India, Delhi
RELEVANT EXPERIENCE_ _________________________________________________________
� Oman Pharmaceutical Products Co.LLC. Muscat, OMAN Nov 2012 – Present
Regulatory Affair Executive
• Responsible for preparation and submission of dossiers in MENA countries, ASEAN
markets and other ROW countries (Oman, GCC, Philippines, Myanmar, Vietnam,
Srilanka, Cambodia, Singapore, Afghanistan, Saudi Arabia, Jordan, Iraq, UAE, Azerbaijan
and West Africa)
• Preparation, compilation, publishing and validation of documents in NEES/eCTD.
• Preparation of dossier in CTD/ACTD format as per market requirement.
• Checking of dossiers/ Artworks/technical documents received from plant and other
organizations.
• Review of stability data protocol based on stability specification.
• Review of Release and shelf life specification as received from QA before submission.
• Review of In-process testing parameters, analytical methods and specifications used for
testing.
• Review of Clinical documents.
• Response to various regulatory queries received from various regulatory agencies in
coordination with plant R&D & ADL.
• Coordination with various regulatory agencies to fasten the procedures as an when
required by customer.
• Collaborate with QA for availability of documents.
• Planning of dossiers and to be ready for submission on request
• Responsible for maintaining record of Dossiers / query throughout the registration
cycle.
• Preparation and submission of Samples
• Indenting of reference standard, Innovator samples and other QC lab requirements as
per request.
• Supporting Purchase department for various Technical queries related to QA & RA and
co-ordination with customer for timely availability of various documents.
� Alembic Pharmaceuticals Limited, Vadodara June 2011 - June 2012
Worked as a Trainee Project Management Formulations & Development
• Coordinate with Purchase Dept. and ensure procurement of API & Excipients.
• Regular coordination with respective departments for smooth and timely lab scale
development.
• Tracking of formulation Projects as per its given timelines; monitor it throughout the
project and periodical internal review, monthly reports.
• Ensuring for the availability of Stability protocols and stability charging within a time
frame from QA and availability of stability data from QC.
• Coordinate with various departments for the availability of documents related to FDA
queries.
• Coordinating with various departments QA, QC, Production, F&D and Packaging for
technical data and document required for dossier.
• Coordinating with BE department for protocol preparation and scheduling for the BE
studies also Tracking for availability of Investigational products and its report timelines.
• Ensure various clearances (License application, BENOC application and innovator
application) and certifications from Regulatory bodies and other agencies for
development projects and also ensure timely submission of all dossiers from RA
department.
� Synbiotics Pharmaceutical Ltd (Dabhasa, Vadodara) June 2008 to June 2009
Worked as QA OFFICER
• Responsible for preparation of SOP, SMF, VALIDATION PROTOCOL
• Reviewing DMF
MPHARM PROJECT______________________________________________________________
• Development, Evaluation and optimization of Immediate Capsule (F&D Department.
Alembic Ltd, Gorwa, Vadodara)
Guided by: Mr. Muthulingam
Principal Scientist,
F&D Department, Alembic Ltd, Gorwa, Vadodara
• Formulation, Evaluation and Optimization of Oral Self Micro emulsifying Drug Delivery
System (Parul Institute of Pharmacy, Limda, Vadodara), Guided By: Dr.Rajesh K.S, Mrs.
Sona. P. S
AREA OF INTREST ______________________________________________________________
• International Regulatory Affair (Formulation)
• Project Management (Formulation)
SCIENTIFIC EXPERTISE __________________________________________________________
• Well versed with scientific software like Design-Expert 7.1.6 version.
• Critical understanding and appreciation of pharmacopoeias (USP, IP), and regulatory
guidelines like USFDA (INDA, NDA and ANDA), MCC, EMEA, TGA, ANVISA, ICH, WHO
GMP, GCC, SFDA, JFDA guidelines, Stability studies & BE studies.
SKILLS & STRENGTH____________________________________________________________
• Proficient in using computer especially MS OFFICE (MS Word, MS Excel, MS PowerPoint)
and internet surfing.
• Working knowledge of SAP
• Knowledge of Intellectual Property
• Proficient in information retrieval from Internet including literature search, etc.
• Knowledge of Pharmaceutical Statistics and optimization techniques
• Multilingual, with proficiency in English, Gujarati and Hindi
• Honest and dependable with excellent interpersonal skills
• Team oriented, organized and manage time well
• Friendly; have good presentation skills
DECLARATION_________________________________________________________________
Date: 04-07-2015 Nidhi R. Shah
I hereby declare that all the information given above is true to the best of my knowledge.
Yours Faithfully,
