parth shah
@parthshah11
Project Manager driving global regulatory programs and data-driven delivery improvements.
IndiaWhat I'm looking for
Project Manager with 4+ years leading global regulatory programs for medical device, pharmaceutical, and healthcare clients across the US, EU, APAC, ANZ, and MEA. I own the full lifecycle — from contract award through health authority approval to product importation — coordinating regulatory affairs, quality, medical writing, and commercial teams across regions and time zones.
At Freyr Solutions, I've delivered 30+ global regulatory and healthcare programs, cut delivery delays by 15% through structured governance frameworks, and built the risk, budget, and reporting systems that give leadership real-time visibility into multi-region project portfolios.
Background: M.Pharm + MBA (Pharma Technology & Marketing), NMIMS Mumbai. Comfortable operating at the intersection of regulatory strategy, project governance, and client relationships — and increasingly interested in how AI and digital tools are reshaping regulatory operations.
Open to remote project management and regulatory affairs roles, and regulatory consulting engagements, globally.
📩 shahparthmanish@gmail.com
Experience
Work history, roles, and key accomplishments
Project Manager, Regulatory & Healthcare
Freyr Solutions India
Jun 2022 - Present (4 years 1 month)
Led end-to-end regulatory program delivery for US FDA, EU MDR, TGA, and PMDA jurisdictions, supporting multi-region portfolios across healthcare and medical devices. Managed governance, risk/issue tracking, cross-functional coordination, client escalations, and program budgets through health authority approval and product importation.
Sales Management Intern
Sylis Technologies
Aug 2021 - Sep 2021 (1 month)
Supported business development activities for healthcare digital solutions, including market research, lead identification, and outreach coordination. Helped prepare client-facing materials and coordinate follow-ups to improve pipeline visibility.
Trade Intern
Shree Krishna Agency
Sep 2020 - Present (5 years 10 months)
Assisted with day-to-day pharmacy trade operations, including inventory tracking, order processing, and vendor coordination. Built foundational exposure to pharmaceutical distribution workflows and retail pharmacy operations.
Education
Degrees, certifications, and relevant coursework
NMIMS Mumbai
M.Pharm + MBA, Pharma Technology & Marketing
Grade: CGPA: 8.24/10
Completed M.Pharm + MBA studies in Pharma Technology & Marketing at NMIMS Mumbai, achieving a CGPA of 8.24/10.
Charotar University of Science and Technology (CHARUSAT)
Bachelor of Pharmacy (B.Pharm), Pharmacy
Grade: 69.16%
Completed B.Pharm at CHARUSAT University, achieving 69.16%.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Salary expectations
Social media
Job categories
Skills
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