PRUTHA PEDNEKAR

Master’s in pharmacy,
Regulatory Affairs Professional
+971 50 9124009 / +971 58 900 2269
Belgium Visa Type -D and Golden Visa UAE
UAE Licensed Pharmacist
pednekarprutha@gmail.com
https://www.linkedin.com/in/prutha-pednekar-7624016a/

PROFILE WORK EXPERIENCE

Regulatory Compliance Professional, Senior Regulatory Affairs officer
with 10+ years of experience in the Life G42 CNBG Life Sciences cluster, Abu Dhabi, UAE
science industry. As a qualification, I June 2021 – Present
hold master’s degree in pharmacy.
Experienced in the registration of • Leads project for the region or globally for New marketing authorization,
Pharmaceuticals, Biologicals and Health authority queries, QC analysis, Life cycle maintenance (post-
Medical devices/IVD across Middle East, approval changes, variation, license renewal, Artwork/Labelling update,
Africa, ASEAN, Colombia, Serbia and baseline submission) for:
Pakistan. Human Vaccines (Biologicals), Recombinant protein - Middle East, Africa,
I have also worked in the field of Quality ASEAN, Colombia, Serbia
in Sanofi & Teva Pharmaceuticals. I am Medical devices (In-vitro diagnostics) – MEA, Central Asia
a flexible worker, well organized, and • Licensing and Registration of manufacturer, marketing authorization holder,
would strive to get the job done. drug store.
• Strategic planning as per the approval timeline and align as per market
strategy.
SKILLS & EXPERTISE • Prepare and review authorization letters, legal drafts,
GCC (Saudi Arabia, UAE, Kuwait, application/registration forms, technical drafts, and declarations.
• Provide technical/CMC review of data or reports that will be incorporated
Bahrain, Oman, Qatar), Egypt, Lebanon,
into regulatory submissions to assure scientific accuracy and clarity of
Jordan, Libya, Iraq, Sudan, North Africa presentation.
(Algeria, Morocco, Tunisia), French West • Build a good relationship with internal & external stakeholders with
continuous interaction to meet business challenges.
Africa (Cameroon, Mali, Gabon, Ivory
• Packaging artworks, promotional materials, labeling, batch records,
Coast, Senegal), Sub Sahara Africa specification sheets, or test methods for compliance with applicable
(Kenya, Nigeria, Uganda, Tanzania, regulations and policies.
• Communicate with service providers, regulatory agencies, or other
Ghana), South Africa, ASEAN,
stakeholders regarding pre-submission strategies, potential regulatory
Colombia, Serbia, and Pakistan. pathways, compliance with dossier requirements, or clarification and follow-
• Regulatory submissions up on submissions for timely approval of the product.
• Regulatory Due diligence, planning • Provide logistics support and prepare import-export letters for smooth
shipment clearance.
• Electronic Common Technical • Preparation of database, trackers, quarterly reports.
Document (eCTD) and Non- eCTD • Regulatory strategy and due diligence.
(NeeS and paper) dossier formats. • Liaising with PV team and the Regulatory bodies for safety report submission.
• Archiving and maintaining the trackers, and quarterly reports, and keeping
updated on any outstanding activities.
• Prepare SOP (Standard operating procedures) for regulatory department.
 Regulatory Manager
Axis Healthcare Consultancy, Dubai UAE
• Licensing of legal manufacturers,
June 2020 – May 2021
marketing authorization holders, • Medical Device registration process, Health authority queries for:
physical manufacturer and authorized Medical devices (In-vitro diagnostics) - GCC, Iraq, Kurdistan, and Morocco.
representative. Rare disease - Saudi Arabia.
• Provide scientific advice, training, and meeting with internal and external
• Life cycle maintenance of the product clients/ customers.
(License renewal, variations/change • Oversee and coordinate Regulatory Affairs specialists to achieve submission
control, post-approval activities, targets and guide them along.

baseline)
Regulatory Affairs Specialist
• Artworks/Labelling management Mundipharma Middle East and Africa, Dubai, UAE
• Classification/ Listing February 2016 – April 2020
• New marketing applications, Health authority queries, QC analysis, and Life
• Health authority queries and
cycle maintenance (post-approval changes, variation, license renewal,
interactions. Artwork/Labelling update, baseline submission) for: Pharmaceutical
(Narcotics/Opioid Analgesic, Oncology, Orphan, Respiratory,
• Price assessment and price appeal.
Ophthalmology, Pediatric planning)– Middle East, Africa, Pakistan
• Logistics support in applying Import • Responsible for timely provision of data to database tools for submission,
export permit approval, and post-approval activities.
• Play an active role in the definition of the registration roadmap and timelines
• Tender listing
to achieve registration strategy globally.
• Final report preparation. • Support cross-functional alignment initiatives to ensure compliance on
Regulatory activities.
• To ensure compliance and ethics
• Maintenance of project plans, project trackers and regulatory intelligence
tools as it pertains to assigned responsibilities and submission of annual
SOFTWARE SKILLS •
reports.
Liaising with PV team and the Regulatory bodies for safety report
submission.
• Athena
• STAR
Additional Experience
• ReCoRD
• Quality Officer, Life Pharma FZE, UAE
• Workday, HRworks
(June 2015 – Jan 2016)
• Glorya
• Executive - Method Development, Teva Pharmaceuticals, India
• Empower 2 chromatographic
(April 2013 – October 2014)
• MS Office (Word, Outlook, Power Point,
• Research Scientist – Quality Control, Sanofi Synthelabo Ltd., India
Excel)
(November 2012 – April 2013)
• Adobe Photoshop, ChemDraw.

EDUCATION ACHIEVEMENTS AND PUBLICATIONS

• Awarded by APTI (Association of Pharmaceutical Teachers of India) for the
Master’s in Pharmacy
best scientific paper published in the year 2020 for the research paper “In-
(Pharmaceutical Chemistry)
vitro Metabolism of Risperidone on Isolated Microsomes of Rat Liver:
University of Pune
Metabolite Identification and profiling by RP-HPLC and LC-MS techniques”
2012
published in the journal of IJPER. https://www.ijper.org/article/956
• Published research paper “Synthesis and evaluation of 1,2,4-triazole
Bachelor’s in Pharmacy
derivatives as antimicrobial, antifungal and anthelmintic agents” in the
Goa University
journal of Indian Journal of Chemistry (IJC).
2010
http://op.niscpr.res.in/index.php/IJC/article/view/66354/465481659
• Published research paper “Natural Indicators as an alternative to Synthetic
OTHER INFORMATION acid-base indicators” in the journal of Indo American Journal of
Pharmaceutical Sciences.
Languages: Business English (C.1.2)
https://www.iajps.com/issue_17november.php
French (A.1.1)