Pradhan Kapadia
Associate Manager, Site Readiness at Fortrea Drug Development Inc.
- Role
- Associate Manager, Regulatory Submissions at Fortrea
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Pradhan Kapadia
I am a Regulatory Affairs professional specialising in global regulatory submissions…
Experience
Associate Manager, Regulatory Submissions
Oct 2019 — Present
Moving into the clinical trial regulatory submission have been exciting. My work focus on achieving the regulatory approval, planning/strategizing submissions and collaborating with cross-functional team. Understanding the needs of clients and helping them to have the speedy approvals.Key Roles and Responsibilities: Providing line management and support to direct reports during study activation and maintenance Upload of submission documentations to Clinical Trials Information System (CTIS) Plan, compile, review and submission of initial Clinical Trial Application (CTA) and life cycle management of the clinical study. Applying and maintenance of study specific Import License. Plan, organize and collaborate with team for Subject Expert Committee (SEC) meeting with CDSCO (India). Managing post approval maintenance submissions like Protocol Amendment, Minor amendment, EOT notification, periodic study progress reports, etc. Registering the study to the public registry website and its maintenance Review of the Clinical documents like Study Protocol, IB, IMPD, ICFs etc. Assist in the coordination, collection and organization of data and information required by Regulatory Authorities. Assure compliance with regulatory requirements in relation to assigned projects. Participate in project development and regulatory strategy planning sessions. To participate independently in client meetings and will proactively liaise with clients on regulatory submission issues. Excellent knowledge of EUCTR submissions. Supporting Local Ethic committee (EC) submission. Resolving queries from EC.
Education
N.G.S.M. INSTITUTE OF PHARMACEUTICAL SCIENCES
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
2006 — 2010
Lal Bahadur Shastri English Medium Scool, Rajkot
Primary Schooling, Basics
1994 — 2002
Sikkim Manipal University - Distance Education
Master of Business Administration - MBA, International Business
2014 — 2016
Saurashtra University
M.pharm, Pharmaceutical Regulatory Affairs
2011 — 2013
Skills
- CRO
- Nda
- Pharmaceutical Industry
- Sop
- Fda
- Clinical Research
- Regulatory Requirements
- Regulatory Affairs
- Pharmaceutics
- Validation
- Anda
- Regulatory Submissions
- Electronic Common Technical Document (Ectd)
- Pharmacovigilance
- Gmp
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