1 Remote Full-time fda jobs in Bombay, India.

... internal, customer, and regulatory audits. - Collaborate with cross-functional teams to support document management activities. - Ensure compliance with GDP, GMP, FDA regulations, ISO standards, and company policies. - Lead document control investigations, Change Controls, CAPAs, and continuous improvement initiatives. - Train, ...

... Tasks & Responsibilities Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs) Issue LOA drafts for US-FDA Health Canada and NMPA China. Maintain LOA data base prepare analysis and share with the sales teams as required Prepare weekly data packages for DMFs & support ...

... effectively within global cross-functional teams Preferred Qualifications Oncology experience is highly desirable but not required. Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies. Experience supporting global development programs. [{"name": "full_time", "text": "Full time", "categoryName": ...

... independently in a fast-paced, highly matrixed environment. Preferred Qualifications Oncology experience is highly desirable but not required. Experience interacting with FDA, EMA, PMDA, and other global regulatory agencies. Experience supporting global development programs. [{"name": "full_time", "text": "Full time", "categoryName": ...

... enterprise applications • Demonstrated success managing IT projects and leading digital transformation initiatives • Experience working in regulated environments (GxP, FDA, etc.) and ensuring compliance • Advanced knowledge of ITIL processes, IT security best practices, and risk management • Excellent stakeholder management and ...

... impurity qualification, extractables and leachable assessments, and product safety profiles. - Monitor evolving global regulations and guidance documents (ICH, FDA, EMA, WHO, and regional requirements) relevant to toxicology and impurity assessment. Required Experience - 3-5 years of experience in toxicology, safety assessment, ...

... expertise in relevant technical domains (e.g., diagnostics, biologics, instrumentation) • Strong understanding of quality systems and regulatory requirements (FDA, ISO, GMP) • Experience managing complex projects, budgets and resources • Strong leadership abilities with demonstrated success building and developing teams ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... platforms (AWS, Azure, Google Cloud) - Monitor, retrain, and maintain models in production (MLOps practices) - Ensure compliance with healthcare regulations (HIPAA, FDA, GDPR as applicable) - Apply ethical AI practices, including bias detection and model transparency - Stay updated with advancements in AI, healthcare analytics, ...