Rupesh Phale
Assistant Manager at Glenmark Pharmaceuticals
- Role
- Assistant Manager at Glenmark Pharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Rupesh Phale
Experienced Regulatory Affairs Professional with a demonstrated history of working in the…
Experience
Assistant Manager
Oct 2024 — Present · Panvel Taluka, IN
Roles & Responsibilities:• Timely review the eCTD compiled Abbreviated New Drug Applications (ANDA) for US market, MA\'s for EU and ANDS for Canada.• To ensure quick turnaround time to respond Agency(s) deficiency letters (i.e. IR, CR, ECD, DCP or National MA queries, NoN, NoC, NoD etc.) from FDA/EU/Canada. Review and edit source response and summary prepared by others for completeness and regulatory compliance - utilizing technical and regulatory knowledge and acumen to drive projects.• Strong review of technical data required for compilation of deficiency’s response & submission (i) API Data: Thorough DMF review, API- specifications and methods/detailed understanding of AMV requirements and parameters included/ Stability/ Photostability and Forced degradation, etc.(ii) FP Data: Thorough review of FP data such as PDR/ Process Validation/ Understand intricacies of impurity profiling of FP w.r.t. API & their impact, FP specifications and methods/ detailed understanding of AMV requirements and parameters included/ stability/ Photostability and Forced degradation, Knowledge about Regulatory guidance.• Review the documents because of GAP analysis and closely works with R&D, projects and plant.• To prepare and send final approval package on receipt of dossier approval letter to the respective plant with all the instructions and commitments listed upfront or as on need basis to respective stakeholders.• Actively involved in Deficiency and Regulatory compliance database management and product summaries for quick updating of ANDA/ANDS/MA deficiencies and status. Provide current FDA/Health Canada/EMA Regulatory guidance/expectations to all stakeholders.• Provide regulatory support to different stakeholders such as Departments of Research and Development - Operations (Commercial, Manufacturing)- Project management team - Manufacturing facilities - Corporate Quality Assurance - Business development – Intellectual Property Rights.
Education
ASPM's K.T. Patil College of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences
University of Mysore
Master of Business Administration - MBA, Pharma and Biotechnology
Skills
- Technology Transfer
- Regulatory Affairs
- Hplc
- Formulation
- Pharmaceutical Industry
- Sop
- Pharmaceutics
- Gmp
- Validation
- Quality Assurance
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