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Experienced pharmaceutical professional specializing in clinical and scientific writing, regulatory affairs, and quality assurance.
Experience
Scientific Medical Writer
Springer Nature Technology and Publishing Solutions
Regulatory Affairs Associate
Cipla
Quality Assurance Executive
Shriji Polymers India Ltd.
GCP-focused Quality Assurance leader with 12+ years ensuring regulatory compliance and audit readiness.
Experience
Quality Assurance Manager
Audubon Bioscience
May 2021 - Jun 2025 (4 years 1 month)
Medical Expert – QA & Compliance
LLC Doctor Online
Jan 2018 - May 2021 (3 years 4 months)
Clinical Verification Doctor
DILA Medical Laboratory
Skilled Senior Clinical Data Manager with expertise in oncology trials.
Experience
SR Clinical Data Manager
TRANSITIONAL DRUG DEVELOPMENT (TD2)
Jul 2023 - Present (2 years 4 months)
CLINICAL DATA MANAGER II
SDC (Statistics & Data Corporation)
Nov 2019 - Jun 2023 (3 years 7 months)
Clinical Data Manager II
SYNEOS HEALTH, US
Senior Clinical Research Associate with extensive trial management experience.
Experience
FSP Senior CRA I
Thermo Fisher Scientific
May 2025 - Present (6 months)
FSP CRA II
Thermo Fisher Scientific
Aug 2023 - May 2025 (1 year 9 months)
CRA I
Thermo Fisher Scientific
Mar 2023 - Aug 2023 (5 months)
Experienced marketing strategist and product leader in biopharmaceuticals.
Experience
Sr. Global Product Manager
ThermoFisher Scientific
Jan 2022 - Present (3 years 10 months)
Sr. Global Product Manager
SCIEX - Danaher
Jan 2021 - Jan 2022 (1 year)
Sr. Product Manager
Intabio
Feb 2020 - Jan 2021 (11 months)
I am a QA specialist in biopharma with 9+ years GMP and downstream manufacturing expertise.
Experience
QA Specialist CGT
Novartis
Jun 2020 - Jun 2023 (3 years)
Downstream Processing Specialist
Alvotech
Sep 2018 - Feb 2020 (1 year 5 months)
Production Scientist
Piramal Healthcare
Aug 2017 - Aug 2018 (1 year)
Intermediate-quality supervisor with chemical engineering background and strong laboratory and ISO audit experience.
Experience
Quality Supervisor
PLX Inc.
Aug 2024 - Present (1 year 3 months)
Analytical Chemist
Estée Lauder Companies Inc.
Apr 2022 - Aug 2024 (2 years 4 months)
Quality Technician
Dynamic Events Manager with 10+ years of experience
Experience
Commercial Events Project Manager
Mycovia Pharmaceuticals
Jan 2022 - Jan 2023 (1 year)
Marketing Operations and Events Manager
Alimera Sciences
Jan 2015 - Jan 2022 (7 years)
PROJECT COORDINATOR
TÜV SÜD America
Jan 2012 - Jan 2015 (3 years)
Passionate regulatory professional with over 13 years of experience.
Experience
Regulatory Compliance Professional
Spectrum Chemical Mfg. Corp.
Mar 2022 - Present (3 years 8 months)
Team Lead & SME – Regulatory Submission Management - Product
Freyr Solutions
Apr 2020 - Present (5 years 7 months)
Quality Associate with 10 years of pharmaceutical industry experience.
Experience
Quality Associate (Consultant)
Prothena Biosciences
Nov 2023 - Present (2 years)
Senior Compliance Analyst
Norbrook Laboratories
Aug 2020 - Present (5 years 3 months)
Senior clinical operations leader driving compliant, efficient clinical trial delivery.
Experience
Clinical Trials Manager
Denver Health
Jan 2023 - Present (2 years 10 months)
Senior Manager, Operational Feasibility
CVS Health Clinical Trial Services
Jan 2022 - Jan 2023 (1 year)
Senior Manager, Study Management
Experienced Senior Medical Writer with expertise in regulatory documents.
Experience
Senior Medical Writer
ICON plc
Jan 2023 - Present (2 years 10 months)
Medical Writer
MINA MEDICAL CENTRE
Jan 2020 - Present (5 years 10 months)
Experienced Patent Agent specializing in pharmaceutical innovations.
Experience
Patent Agent
Self Employed
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)
Strategic digital product leader specializing in clinical trial innovation.
Experience
Digital Product Manager, Clinical Trials
Pfizer
Jan 2020 - Jun 2024 (4 years 5 months)
Senior Manager, Client Partner
Pfizer
Dec 2017 - Jan 2020 (2 years 1 month)
Senior Information Manager, Clinical Trial Solutions
Pfizer
Oct 2016 - Dec 2017 (1 year 2 months)
Seasoned Global Regulatory Leader with expertise in FDA and EMA processes.
Experience
CMC New Products Sterile Specialist
Pharmathen SA
Jan 2022 - Present (3 years 10 months)
Team Leader - Regulatory Affairs
Apotex Research Private Limited
Mar 2021 - Present (4 years 8 months)
Head (Assistant Manager) - Regulatory Affairs
Detail-oriented Clinical Research Associate with extensive trial management experience.
Experience
Lead Clinical Research Coordinator
Neurology Diagnostics Inc.
May 2024 - Present (1 year 6 months)
Clinical Research Coordinator
Neurology Diagnostics Inc.
Dec 2021 - May 2024 (2 years 5 months)
Senior Quality Assurance Specialist with extensive regulatory compliance expertise.
Experience
Sr. Quality Assurance Specialist
MLM Medical Labs
Jan 2025 - Present (10 months)
Senior Quality Assurance Specialist
HemaCare
Dec 2020 - Dec 2024 (4 years)
Associate Scientist
AmerisourceBergen
Jul 2018 - Apr 2020 (1 year 9 months)
Passionate leader in Marketing and Medical Affairs with project management skills.
Experience
Market Access & Public Affairs Manager
Sandoz
Jan 2023 - Present (2 years 10 months)
Medical Affairs Manager
Consumer Healthcare
Jun 2021 - Jan 2023 (1 year 7 months)
Medical Advisor & MSL
Cardiovascular
Jan 2019 - Jun 2021 (2 years 5 months)
Detail-oriented Medical Device Labeling Specialist with 10+ years experience.
Experience
Regulatory Labeling Specialist
Naturich Labs Inc.
Aug 2024 - Present (1 year 3 months)
Regulatory Compliance Specialist
SGS & Co
Dec 2023 - May 2024 (5 months)
Labeling & Product Packaging Designer
Jun 2016 - Dec 2018 (2 years 6 months)
Feb 2017 - Oct 2019 (2 years 8 months)
Clinical Data Manager I
IQVIA, US
Apr 2015 - Feb 2017 (1 year 10 months)
Clinical Data Coordinator
ALIMENTIV, CA
Sep 2013 - Feb 2015 (1 year 5 months)
Assistant Site Manager
Kentucky Pediatric/Adult Research
Oct 2022 - Mar 2023 (5 months)
Lead Study Coordinator
Kentucky Pediatric/Adult Research
Feb 2022 - Oct 2022 (8 months)
Research Scientist
ProteinSimple
May 2019 - Feb 2020 (9 months)
Research Scientist
Bristol Myers Squibb
Jan 2015 - May 2019 (4 years 4 months)
Project Associate
PPD
Jul 2016 - Jul 2017 (1 year)
Production Pharmaceutical Operator
AMRI
Jun 2015 - Jun 2016 (1 year)
LNK International Inc.
Oct 2021 - Apr 2022 (6 months)
Regulatory Scientist - Regulatory Operation
Kinapse India (A Syneos Health Company)
Feb 2017 - Present (8 years 9 months)
Manager – Regulatory Operation
Amneal Pharma Ltd.
Jun 2016 - Present (9 years 5 months)
Regulatory Scientist – Reg, CMC & Publishing Outsourcing
Kinapse India Scientific Services Pvt. Ltd.
Nov 2011 - Present (14 years)
Senior Quality Control Analyst
Pfizer
Sep 2018 - Present (7 years 2 months)
Senior Quality Control Analyst
Pfizer
Jul 2017 - Present (8 years 4 months)
Quality Control Analyst
Pfizer
Jul 2013 - Present (12 years 4 months)
CVS Health Clinical Trial Services
Jan 2020 - Jan 2022 (2 years)
Senior Manager, Project Management
Coram Clinical Trials
Jan 2017 - Jan 2020 (3 years)
Senior Scientist
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)
Product Manager
Cogstate
Aug 2012 - Oct 2016 (4 years 2 months)
Systems Validation Program Manager
Molecular NeuroImaging
Feb 2009 - Aug 2012 (3 years 6 months)
Harman Finochem
Oct 2020 - Present (5 years 1 month)
Senior Regulatory Affairs Specialist
PAR Formulations Pvt Ltd
Oct 2018 - Present (7 years 1 month)
Senior Executive - Regulatory Affairs
Strides Pharma Science Limited
Jun 2017 - Present (8 years 5 months)
Quality Assurance Specialist
Cognate Bioservices
Jul 2014 - May 2018 (3 years 10 months)
Global Medical Trainer
Immunology / Rare Disease
Jan 2017 - Jan 2019 (2 years)
Medical Advisor: Expert Relationships
Diabetes
Jan 2016 - Dec 2017 (1 year 11 months)
New World Medical Inc.
Aug 2022 - Nov 2023 (1 year 3 months)
Labeling Associate
Smith and Nephew Inc.
Sep 2021 - Aug 2022 (11 months)
Regulatory Affairs Associate
Galderma Laboratories, LLC
Feb 2018 - Sep 2021 (3 years 7 months)