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  • Thorough knowledge of QMS/ ISO 13485 / Regulatory affairs Thorough knowledge of QMS/ ISO 13485 a regulatory subject matter expert through cross functional collaboration with R&D and relevant stakeholders to ensure regulatory compliance healthcare ind

  • Thorough knowledge of QMS/ ISO 13485 / Regulatory affairs Thorough knowledge of QMS/ ISO 13485 a regulatory subject matter expert through cross functional collaboration with R&D and relevant stakeholders to ensure regulatory compliance healthcare ind

  • The Senior Specialist/Associate Manager I may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory Project Management, Global Labelling Management and Dossier Management. The Senior Specialist/Associate Manager I/II is expected to be able to work flexibly

  • Organization Name : Top Pharma Dept : Regulatory Affairs Years of experience : 4- 9 Years Work Location : Bangalore Source Location : India US Market and Europe Markets We are looking from Top Global Pharma And CRO's Candidates must have experience in below mentioned points. Dossier Management

  • Organization Name : Top Pharma Dept : Regulatory Affairs Years of experience : 4- 9 Years Work Location : Bangalore Source Location : India US Market and Europe Markets We are looking from Top Global Pharma And CRO's Candidates must have experience in below mentioned points. Dossier Management

  • Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope. o Review audit reports from the systems and resolve errors to ensure integrity of data o Identifies issues and provides input into solutions o Technical Skill Requirements o Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat. o Proven ...

  • Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope. o Review audit reports from the systems and resolve errors to ensure integrity of data o Identifies issues and provides input into solutions o Technical Skill Requirements o Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat. o Proven ...

  • Perform data entry and quality control tasks associated in all global regulatory systems impacted, including systems associated with the regulatory data scope. o Review audit reports from the systems and resolve errors to ensure integrity of data o Identifies issues and provides input into solutions o Technical Skill Requirements o Computer literacy in MS Word/Outlook/Excel/Adobe Acrobat. o Proven ...

  • Primary Responsibilities o Review and interpret the data provided by the PCO to establish the system / tools required to be populated in line with current standard operating procedures or business process documentation, including systems and SOPs associated with the regulatory data scope. o

  • Dept : Regulatory Affairs Years of experience : 4-8 Years Work Location : Bangalore must have experience in below mentioned points. Dossier Management Labeling License Maintenance Life cycle Management Regulatory Maintenance Description: The Senior Specialist/Associate Manager I is a regulatory

  • Dept : Regulatory Affairs Years of experience : 4-8 Years Work Location : Bangalore Must have experience in below mentioned points. Dossier Management Labeling License Maintenance Life cycle Management Regulatory Maintenance Description: The Senior Specialist/Associate Manager I

  • for leading the end-to-end planning, coordination, and execution of assigned deliverables, including delivery as an Individual Contributor if required. The Senior Specialist/Associate Manager I may take on the accountabilities for a number of different roles within a Global Regulatory Execution Team (GRET): Regulatory

  • efficient submission execution while assuring product compliance through timely and accurate maintenance of CMC product knowledge in CMC Regulatory and PGS quality systems. Main activities for this role include submission strategy responsibilities, systems and regulatory change management compliance ...

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

  • Compilation & review of registration & renewal dossiers, submission of annual report through CTD,eCTD,review of labeling section of the ANDAs Biologics/Injectable Emerging Market (Asia, Africa, CIS & MENA) & National Regulatory Filings (CDSCO) Candidate should have good exposure in Biologics/Injectable Emerging Market (Asia, Africa, CIS & MENA) & National Regulatory Filings (CDSCO ...

  • regulatory submissions and ensures effective data presentation and quality. Author with team members, key pieces of regulatory submissions on need basis. Advices Biosimilars programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with and influences management, cross

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