Pradeep Patil
Blue Star Limited
- Role
- Quality Assurance & Regulatory Affairs Specialist at Blue Star Limited
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Pradeep Patil
A seasoned Regulatory & Compliance professional with extensive experience in managing…
Experience
Quality Assurance & Regulatory Affairs Specialist
Jan 2023 — Present · Mumbai, IN
Collaborates with the Regulatory Affairs team and international regulatory colleagues to provide regulatory support for new products/therapies or changes to existing products-Prepares local, International submissions and work directly with government agencies and/or distributors to obtain product approval/clearance-Monitor and maintain the data as per CPCB requirement for the dispose-off as per Plastic waste management rule and in future to comply with battery waste and upcoming e-waste management regulations by Central pollution control board-Supports review of device labelling and marketing materials for compliance with FDA submissions and applicable regulation-Conducts reviews of product and manufacturing changes for compliance with applicable regulations-Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets-Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team-Supports pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission ISO 13485, ISO 9001, MDR2017, QMS, BIS,(AERB, MoEF, CDSCO, PcPNDT), ISO 14971 Risk management-Supports review of device labelling and marketing materials for compliance with FDA submissions and applicable regulations.
Skills
- Quality Assurance
- Gmp
- Validation
- Regulatory Affairs
- Lifesciences
- Drug Regulatory Affairs
- Formulation
- Pharmaceutical Industry
- Sop
- Technology Transfer
- Analysis
- Patent Law
- Quality System
- V&V
- Patents
- Intellectual Property
- Regulatory Submissions
- Pharmaceuticals
- Regulatory Requirements
- Research
- Change Control
- Cleaning Validation
- Life Sciences
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