197 fda jobs in India.

... in creating analysis datasets, safety and efficacy tables, listings, figures, https://jobeax.com/link/UE15fSbKOKY7scWI, and submission packages compliant with FDA, PMDA, and EMA requirements. Strong knowledge of the clinical drug development process, data automation, safety reporting, DSUR/PSUR deliverables, and Pinnacle ...

... to understand and evaluate complex software, AI/ML systems, and medical devices. - Familiarity with Indian and U.S. legal systems, including HIPAA, DPDP, and FDA/CDSCO regulations. - Strong communication and cross-cultural collaboration skills. We offer competitive benefits to set you up for success in and outside of work. ...

... verbal English communication skills. - Strong organizational and analytical skills with high attention to detail. - Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met. - Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines.

... fleet operations, and preparing operational data and reports. - Agency Hub: Checking port agency costs, including proforma and final disbursement accounts (PDA/FDA), and clearing backlog items. - Vessel IT: Logging tickets, handling user access requests, and maintaining IT documentation for ship and shore users. - Digital ...

... pharmaceutical advertising agency environment - Thorough knowledge of current AMA style; experience with medical/regulatory/legal reviews and familiarity with FDA requirements for drug promotion - Demonstrated comfort and confidence with medical/pharma and industry terminology - Extremely detail oriented, thorough and accurate ...

... or pharmaceutical advertising agency environment Thorough knowledge of current AMA style; experience with medical/regulatory/legal reviews and familiarity with FDA requirements for drug promotion Demonstrated comfort and confidence with medical/pharma and industry terminology Extremely detail oriented, thorough and accurate ...

... of the key certifications include: - ISO 13485:2016 (Quality Management Systems for Medical Devices) - ISO 14971:2019 (Risk Management for Medical Devices) - FDA Compliance (21 CFR Part 820) : Hollister complies with FDA regulations for medical device manufacturing. - CE Marking : For products sold in the European Union, ...

... needed. Preferred - Master’s degree. - PMI certification (PMP) or equivalent. - Certifications or hands-on experience in CQV; CSV awareness; familiarity with FDA 21 CFR Part 11, EU Annex 11, and related regulatory frameworks. - Specific experience delivering validated environments: GMP/GLP labs, ISO 14644 cleanrooms, ISO ...

... ecosystem. - Strong knowledge of medical-device software development and applicable standards, including IEC 62304, ISO 13485, ISO 14971, IEC 60601, and relevant FDA or international regulatory expectations. - Experience leading technical content for regulatory submissions, design assurance, risk management, cybersecurity ...

... in basic computer applications • Fluent in spoken and written English • Excellent interpersonal, influencing and team building skills • Good understanding of FDA, ICH, EMA and GCP guidelines • Working knowledge of relevant safety databases, MedDRA, biostatistics, data management, and clinical operations procedures • Ability ...

... SAP/ERP supply chain touchpoints (e.g., ROH, HALB, WIP, SKU) and how they integrate with PLM data. - Familiarity with regulatory compliance frameworks (e.g., FDA, GHS) and system validation principles. Soft Skills - Analytical Problem Solving: Ability to diagnose and solve complex cross-system master data alignment issues ...

... Risk mitigation strategies - Dust and solvent flammability assessment for pharmaceutical powder handling and solvent-based processes. Preferred experience: - FDA-regulated manufacturing - API or chemical pharmaceutical manufacturing - Hazardous materials storage and processing - Ambitious, energetic, self-motivated, self-managed, ...

... regulatory standards, upstream risks and industry best practices across the enterprise. - Familiar with IT industry frameworks such as ISO27001, NIST, PCI-DSS, FDA, HIPAA: Privacy, HIPAA: Security and HITECH Act. Skills and attributes for success - Provide guidance and share knowledge with team members and participate in ...

... drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. - Very organized and detail-oriented, with effective project ...

... for CAP, Condition surveys, and other SIAS jobs as follows: - To produce SIAS / CAP reports to an agreed format and within an agreed timescale. - To produce CAP FDA reports after analysis received from Naval Architect. - To produce the thickness measurement CAP analysis report. - To produce summary of class survey reports ...

... CRM and data solutions align with applicable pharmaceutical, privacy, security, and records-management requirements, including HIPAA, GDPR, Sunshine Act, and FDA expectations. - Establish security architecture standards for role-based access, classification, privacy, encryption, auditability, retention, and risk management. ...

... that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based ...