933 Usfda Jobs - Page 4

JOB TITLE: Medical Device Regulatory Compliance Specialist JOB SUMMARY: We are seeking a highly motivated and detail-oriented Regulatory Compliance Specialist to play a critical role in ensuring our medical device development processes meet the highest standards of quality and regulatory compliance. The ideal candidate will have hands-on experience with technical documentation, quality systems, and regulatory submissions, and will play a key role in ensuring product safety and compliance throughout the development lifecycle, specifically focusing on the Design History File (DHF) and Device Master Record (DMR). RESPONSIBILITIES: Support the preparation and maintenance of USFDA and EU MDR-comp...

JD @ QC Executive will ensure that products meet quality standards & regulatory requirements with analyzing samples, conducting tests, maintaining documentation & more. Accommodation, Meals & Transport from company side Saturdays are Half day

Coordinate regulatory submissions and ensure compliance with relevant laws and regulations. Prepare and review regulatory documents, including applications and reports. Collaborate with cross-functional teams to meet regulatory requirements. Required Candidate profile Strong knowledge of employment firms and recruitment services. Excellent communication and coordination skills. Ability to work effectively in a fast-paced environment. Strong analytical skills.

Conduct thorough analysis of clinical trial data to identify potential safety concerns. Develop and implement effective safety protocols to mitigate risks associated with medical devices. Collaborate with cross-functional teams Required Candidate profile Strong understanding of clinical trials, medical devices, and regulatory requirements. Excellent analytical and problem-solving skills. Ability to work effectively in a fast-paced environment.

Candidate should be well-versed with Regulatory guidelines, US-FDA, Health Canada, EMA Compilation, review and submission of ANDA, Controlled correspondences, Scientific package to USFDA and responding to queries. Suggest regulatory pathway during development phase for ANDAs. Handling of product life cycle changes and guide cross functional team for filing strategy Review of DMFs., PDR, Labelling and other product related documentation for ANDA. Establishment registration, re-registration, and submitting annual updates

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

Position Purpose Provide a brief description of the overall purpose of the position, why this position exists and how it will contribute in achieving the teams goal. - Support to oversee the smooth functioning of the department and ensuring consistent provision - Support To manage and motivate all departmental staff - Ensure the financial reporting to Head Office - Accounting production and statutory accounts Responsibilities - Oversee Preparation of the financial reporting sent on a monthly basis to the Head Office: P&L, balance sheet, off balance sheet, annexes, tax book, regulatory reporting schedules - Manage Prepare ad hoc Financial Reportings for Head office upon request - Contribute t...

Job title Quality Management System (QMS) Manager Reports to Operation Head Job purpose : Establishment, implementation, and continuous improvement of the company's. Quality Management System (QMS) to support its clinical-stage biopharmaceutical development programs while ensuring compliance with applicable regulatory requirements (e.g., FDA, EMA, ICH) and GxP standards (GMP, GDP, GCP, GLP). Cross-functional collaboration to embed a proactive quality culture, align GxP activities with corporate quality objectives, and drive operational excellence as the organization advances toward late-stage and commercial readiness. Duties and responsibilities QMS Development & Implementation Develop, impl...

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be align...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song"” all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving client...

KnJ Projects Private Limited is looking for Material cum Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements. Disclaimer : This job description has been sourced from a public domain and may have been modified by Naukri. com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

Job Title: Utility Engineer Department: Process Department ______________ Key Responsibilities: Design and develop clean and black utility systems as per cGMP, USFDA & EU guidelines. Prepare P&IDs, layout drawings, and GA drawings for: PW, WFI, Clean Steam Compressed Air, Nitrogen, Vacuum Chilled Water, Hot Water, HVAC utilities Boiler, RO/DM Plant, Cooling Tower Perform utility load calculations and equipment sizing (pumps, compressors, chillers, etc.). Prepare utility distribution diagrams and interconnection layouts. Coordinate with Process, HVAC & Electrical teams for routing and layouts. Prepare datasheets, equipment specs, and BOQs. Review vendor offers and drawings during procurement....

Skills: visa, sales, australia, canada, immigration, visa process, direct sales,. About The Role :-. Designation-Manager Visa. Working closely with Admission and Counselling Team to educate them about changing Student Visa Rules. Lead the team. Will be the process owner for assigned clients (students) and ensuring that they are serviced and guided well from start to finish of the student Visa application process. Ensuring complete visa application documentation including all the financial & background related papers. Helping team to manage the students and providing advice in preparing the visa files. Liaising with the students to confirm that everything is done before the interview date. Li...

Skills: Counseling, Good communication skill, fresher, excellent, counseling, graduate,. We are hiring Visa Counselor for Amritsar location:. Urgently Required Female Visa Counselor who has an experience of. Study visa Canada, Australia, Uk, Usa Visa Counseling. Making telephonic conversations with our clients and making them clear about the visa processes of countries like Canada, Australia, the Uk, USA. Convert leads to admissions. Handling Walk-In, Telephonic & Email inquiries. Fix appointments for counselors and generate walk-ins. Following up on the prospective students over the phone. Follow-up on the leads till registration. Attending regular team meetings to clarify progress and perf...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

Candidate should be B.Pharm Candidate should have regulatory exposure/ in previous organisation Candidate should have well command on IPQA activities Candidate should have Command on packaging operations Candidate should be able to work in shift well aware with regulatory requirement

Job Title: Manager - Regulatory Affairs / Quality Assurance Company: GreenSignal Bio Pharma Pvt Ltd Location: Gummidipoondi, Chennai, Tamil Nadu Experience: 10-15 years in Quality Assurance and Regulatory Affairs, specifically within the Vaccine, Injectable, and Sterile Industry Educational Qualification: Bachelors or Masters in Pharmacy M.Sc in Biotechnology, Microbiology, or a related field Additional qualifications in life sciences or pharmaceutical sciences are a plus Job Overview: As the Manager QA / Regulatory Affairs , you will play a pivotal role in ensuring that our vaccine , injectable , and sterile pharmaceutical products meet global regulatory requirements and quality assurance (...

Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regul...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...

Be responsible to lead downstream manufacturing compliance. Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item. Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA. Responsible for the review and approval of Master manufacturing records for the commercial batches. Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records. To review an...

About The Role Project Role Software Development Lead Project Role Description Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity. Must have skills Veeva Vault Good to have skills NA Minimum 5 year(s) of experience is required Educational Qualification 15 years full time education Summary We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with signif...

Pfizer Healthcare India Private Limited - Visakhapatnam Hiring Diploma Pharmacy Freshers Job Role - Junior Associates - Manufacturing Eligibility Criteria: Diploma Pharmacy only (2025 Pass out) & Pass Percentage 60% in Academic & No backlogs. Job Description Operate production equipment such as injectable machines, sterile machines, parenteral machines, formulation machines, filling machines, capping machines, compounding machines, washing machines, sealing machines, Visual inspection & packing machines. Monitor and control the production process to ensure quality products are produced within specified parameters. Maintain accurate records of production data and perform routine maintenance t...

Seeking an immediate joiner with 3–8 years’ regulatory experience B.Pharm/M.Pharm. Responsible for CTD/ACTD dossier prep,review,query response,team coordination,regulatory submissions,documentation. Strong R&D,research, communication skills required.