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Dynamic Regulatory Manager with expertise in healthcare compliance and quality assurance.
Experience
Regulatory Affairs Manager
Rossen Darman
Jun 2017 - Present (8 years 5 months)
Regulatory Affairs Expert
KitaRich
Mar 2016 - Jun 2017 (1 year 3 months)
Medical Representative
Unknown
Mar 2015 - Mar 2016 (1 year)
English Teacher
Unknown
Jun 2013 - Mar 2015 (1 year 9 months)
Chemistry Instructor
Unknown
Jun 2012 - Jun 2013 (11 months)
Clinical research regulatory specialist with experience in trial management and client-facing sales.
Experience
Regulatory Affairs Specialist
Methodist Health System Clinical Research Institute
Sep 2021 - Present (4 years 2 months)
Sales Specialist
Apna Bazaar
Jan 2019 - Present (6 years 10 months)
1200k-1500k USD
Senior Regulatory Affairs Manager specializing in medical devices and IVD.
Experience
Senior Scientist
Theranosis Life-sciences
Oct 2020 - Present (5 years 1 month)
Senior Scientist
Detail-oriented Drug Regulatory Affairs Executive with compliance expertise.
Experience
Drug Regulatory Affairs Executive
Aravis Pharmaceutical
May 2024 - Present (1 year 6 months)
Drug Regulatory Affairs Executive
Lucent Biotech Ltd.
Feb 2023 - May 2024 (1 year 3 months)
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Experienced regulatory affairs professional in agrochemicals.
Experience
Regulatory Affairs
AGRI SCIENCES Tarim Ve İlaç Ürünleri San. Ve Tic. Ltd. Şti.
Oct 2021 - Present (4 years 1 month)
Regulatory Affairs
DLT Agro
Jan 2020 - Jan 2021 (1 year)
Regulatory Affairs Analyst
IAF Agro
Jan 2018 - Feb 2020 (2 years 1 month)
I am a Senior Regulatory Affairs engineer advancing global medical device approvals across EU, US, APAC.
Experience
Senior Engineer - Regulatory Affairs
Tata Elxsi Limited
Jan 2023 - Present (2 years 10 months)
QA Intern
Cognizant Technology Solutions Corporation
Mar 2022 - Sep 2022 (6 months)
Biomedical Intern
Passionate regulatory affairs specialist committed to delivering accurate service.
Experience
Regulatory Affairs Specialist
Benby Group of Companies
Jan 2019 - Mar 2025 (6 years 2 months)
Sub-Investigator
Experienced Regulatory Operations Specialist with expertise in eCTD submissions.
Experience
Sr. Clinical Trial Associate
Catalyst Clinical Research
Jan 2020 - Dec 2023 (3 years 11 months)
Corporate Administration Manager
Catalyst Clinical Research
Jan 2019 - Dec 2020 (1 year 11 months)
Regulatory Affairs Specialist / Operations Manager
Biostudy Solutions, LLC
Jan 2015 - Dec 2019 (4 years 11 months)
Postgraduate bioanalytical scientist focused on regulatory affairs, compliance, and lab-based analytical testing.
Experience
Regulatory Affairs Intern
S.H. Kelkar and Company Limited
May 2025 - Present (6 months)
Calibration Technician Intern
AutoCal Solutions Pvt Ltd
Apr 2024 - Jun 2024 (2 months)
Regulatory affairs professional and pharmacist focused on pharmaceutical compliance.
Experience
Regulatory Affairs Associate
Bosnalijek JSC
Nov 2023 - Present (2 years)
Sales Representative
Swixx Pharma - Amicus Pharma
Nov 2022 - Nov 2023 (1 year)
Product Owner
Above BiH
I am an experienced food technologist and regulatory affairs leader driving product development and compliance.
Experience
Part-Time Work
Ipsos Puls d.o.o.
Jan 2010 - May 2013 (3 years 4 months)
Intern in Canned Meat Production
Danica d.o.o.
Jan 2007 - Oct 2007 (9 months)
Detail-oriented Regulatory Affairs professional with FDA compliance expertise.
Experience
Regulatory Affairs Associate
Nexus Pharmaceuticals
Feb 2025 - Present (9 months)
Regulatory Affairs Associate – Publishing
Nexus Pharmaceuticals
Mar 2023 - Feb 2025 (1 year 11 months)
Quality Assurance Associate II
Nexus Pharmaceuticals
Pharmacovigilance and Regulatory Affairs leader driving compliance and product launches.
Experience
Pharmacovigilance and Regulatory Affairs Manager
Genesis Pharma (Cyprus) Ltd
Dec 2019 - Present (5 years 11 months)
Pharmacovigilance and Regulatory Affairs Officer
Genesis Pharma (Cyprus) Ltd
Jun 2018 - Dec 2019 (1 year 6 months)
Regulatory Affairs professional with expertise in formulation development.
Experience
Research Scientist
Encube Ethicals Pvt., Ltd.
Feb 2022 - Present (3 years 9 months)
QC Trainee
Symbiotec Pharmalab Pvt., Ltd.
Oct 2018 - Present (7 years 1 month)
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Experienced Quality Management Systems and Regulatory Affairs Professional.
Experience
Regulatory Specialist / Consultant
Vero-Biotech
Mar 2022 - Present (3 years 8 months)
Senior RAQA Compliance Analyst / Consultant
Stryker Spine
Jun 2021 - Present (4 years 5 months)
Management Consultant / Affiliate
Detail-oriented Regulatory Affairs & Pharmacovigilance Associate.
Experience
Community Pharmacist
SC DUCFARM SRL
Oct 2021 - Present (4 years 1 month)
Bilingual pharmacist specializing in regulatory affairs, quality systems, and compliance.
Experience
Clinical Compliance Support
Mowlam Healthcare
Mar 2024 - Present (1 year 8 months)
GxP Compliance & Pharmacy Technician
Tony O Briens Pharmacy
Oct 2023 - Feb 2024 (4 months)
Medication Traceability Technician
Scanlons Pharmacy
Strategic regulatory leader driving market access for medical devices.
Experience
Manager, Medical Devices
MedTech Europe
Aug 2023 - Oct 2025 (2 years 2 months)
R&D Compliance Engineer
Vision Vent Innovation
Apr 2021 - Jul 2023 (2 years 3 months)
Freelance Engineer
Independent
Feb 2020 - Mar 2021 (1 year 1 month)
Regulatory Affairs & QMS specialist for global medical devices.
Experience
Regulatory Affairs Specialist
Kounter Intuitive Technologies
Aug 2024 - Present (1 year 3 months)
Biomedical Engineering Intern
AlShifa Trust Eye Hospital
Mar 2024 - Jul 2024 (4 months)
Biomedical Engineering Intern
Experienced pharmacovigilance professional with 22 years in compliance.
Experience
Senior Manager, Compliance
Gilead Sciences
Feb 2021 - Present (4 years 9 months)
Associate Director, Clinical Quality Assurance
Immunomedics
Sep 2020 - Feb 2021 (5 months)
Senior Manager, Global Development Process
VNIR Biotech
Feb 2020 - Aug 2020 (6 months)
Senior Scientific Officer
Oriental Advance Life Pvt Ltd
Jan 2018 - Jan 2020 (2 years)
Senior Scientist
Theranosis Life Sciences
Feb 2016 - Apr 2018 (2 years 2 months)
Research Scientist
Biomed Informatics
Jan 2010 - Jan 2016 (6 years)
Development Coordinator
IAF Agro
Jan 2015 - May 2018 (3 years 4 months)
Master Intern
Faculty of Agronomy, University of Buenos Aires
Mar 2013 - Aug 2015 (2 years 5 months)
BGS Global Institute of Medical Sciences and Hospital
Jan 2022 - Feb 2022 (1 month)
Syneos Health
Dec 2021 - Feb 2022 (2 months)
Regulatory Affairs Specialist
New Marketlink Pharmaceutical Corp
Apr 2017 - Dec 2018 (1 year 8 months)
Regulatory Affairs Supervisor
Metro Drug, Inc
Feb 2014 - Apr 2017 (3 years 2 months)
Quality Control Supervisor
Metro Drug, Inc.
Feb 2014 - Aug 2014 (6 months)
Clinical Document Coordinator / Regulatory Specialist
Biostudy Solutions, LLC
Jan 2012 - Dec 2015 (3 years 11 months)
Clinical Document Coordinator
AAIPharma (now Alcami)
Jan 2007 - Dec 2010 (3 years 11 months)
Feb 2022 - Nov 2022 (9 months)
Pharmacy Intern
Sarajevo Pharmacies
May 2020 - Aug 2020 (3 months)
Apr 2022 - Mar 2023 (11 months)
Incoming Quality Inspector
Abbott Laboratories
Sep 2021 - Mar 2022 (6 months)
Laboratory Technician
Teleflex
Apr 2021 - Aug 2021 (4 months)
CAPA Coordinator / Quality Assurance Scientist
Remedica Ltd.
Feb 2017 - Jun 2018 (1 year 4 months)
Quality Representative / Pharmacovigilance Deputy LPPV
G.A. Stamatis Co. Ltd
Apr 2015 - Jan 2017 (1 year 9 months)
Regulatory Affairs Submission Executive
United Europharma Ltd
Oct 2013 - Apr 2015 (1 year 6 months)
ORIEL Stat-A-Matrix
Apr 2020 - Present (5 years 7 months)
RA/QA Specialist
Summit Medical Products
Mar 2019 - Present (6 years 8 months)
Senior Supplier Quality Engineer / Consultant
Stryker Neurovascular
Oct 2018 - Present (7 years 1 month)
Sep 2022 - Oct 2023 (1 year 1 month)
Supply Chain Compliance Assistant
O Sullivans Pharmacy
May 2022 - Sep 2022 (4 months)
Regulatory Compliance Pharmacist
UPA Copacabana
Jun 2019 - Apr 2022 (2 years 10 months)
Simulation Engineer
OnRenewables, S.L.
Nov 2017 - Aug 2019 (1 year 9 months)
Rawalpindi Institute of Cardiology
Aug 2023 - Dec 2023 (4 months)
Regeneron Pharmaceuticals, Inc.
Jan 2018 - Sep 2020 (2 years 8 months)
Director, Pharmacovigilance Compliance
The Medicines Company
Apr 2015 - Jan 2018 (2 years 9 months)
DSP Compliance Manager
Glaxo Smith-Kline / Novartis Consumer Health
Jul 2008 - Apr 2015 (6 years 9 months)