161 Fda Jobs - Page 2

QMS Implementation Audit facilitation: will represent the company during regulatory/ 3rd party audits: MHRA, USFDA, MCC, WHO, etc. Products: temperature-controlled packaging & temperature monitoring systems used for storage & transit of medicines Required Candidate profile Any science graduates 10-15 years' experience in quality, ideally in pharma/ medical devices/ equipment manufacturing industry International Audit Experience mandatory Should be open for global travel

Job Description Candidate shall manage projects from concept to commercialization, ensuring projects stay on time, within budget, and meet regulatory requirements. • Develop project plans, manage resources, monitor progress, and handle changes to achieve project goals, while also ensuring compliance with relevant regulations, like FDA and EU guidelines • Communicate effectively with stakeholders, including clients, management, and internal Cross-functional teams Roles & Responsibility Demonstrated proficiency in the following areas: • Strong understanding of product development lifecycle, design controls, and regulatory requirements. • Experience in managing medical device development projects or related fields. • Knowledge of relevant regulations and standards in the medical device industry. • Excellent communication, interpersonal, and leadership skills • Ability to manage multiple projects simultaneously and meet deadlines • Project management certifications (e.g., PMP, Scrum) is preferred • Proficient in project management tools (e.g., MS Project, Jira). General Skills • Self-motivated and able to work independently with minimal supervision. • Must be a good team player and able to adapt to the work environment. Must have good verbal and written communication and interpersonal skills with good working attitude.

The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting and product distribution restriction requirements for the change within the change control management system. Liaise with other functions, including Process Development, Operations, Quality and Supply Chain to ensure alignment of regulatory strategies What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a type of person with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Associate’s degree and 6 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Diploma and 8 years of manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Degree in Life Science discipline Regulatory CMC specific knowledge & experience Understanding and application of principles, concepts, theories and standards of scientific/technical field Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture 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 clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services. Employees under this span will be a part of one of the sub-offerings - Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The incumbent will perform the regulatory affairs tasks of submission in accordance with ICH guidelines and other Health Authorities, review and transform Source Documents. Perform Quality Control (Document QC) checks for all submission components. Veeva Regulatory Suite experienceCollect, collate and evaluate the scientific data gathered as part of R & D. Advise on legal and scientific restraints and requirements. Ensure the organization`s products comply with current regulations. Example; Build regulatory submission strategy, author CMC documents, and health authority packages etc. What are we looking for Life Sciences Regulatory ServicesAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to perform under pressureAbility to work well in a teamLife Sciences Automation Enablement Roles and Responsibilities: In this role you are required to do analysis and solving of lower-complexity problems Your day to day interaction is with peers within Accenture before updating supervisors In this role you may have limited exposure with clients and/or Accenture management You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments The decisions you make impact your own work and may impact the work of others You will be an individual contributor as a part of a team, with a focused scope of work Please note that this role may require you to work in rotational shifts Qualification Master of Pharmacy

IVL India Environmental RD is looking for 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.

Quality Control Dept, ensuring Timely testing & quality check of Raw Materials and Finished Products. Analysis on equipment like HPLC, FTIR, GC etc, all other Q.C. related matters Required Candidate profile Experience in handling HPLC, FTIR, GC etc, for 3 to 7 yrs, Experience in Quality Control dept. of Pharma Company. FDA Approval Required. Perks and benefits Apply with Salary Drawn & Expected Salary

Role & responsibilities QA Documents Preparation, review, & revision (such as Work Instructions, Flowcharts, SOPs, Inward Quality Plan, Technical Data Sheet, Formats, etc.) Document Control (Soft copy & Hard copy) Coordinate with QC, Production, Design team & management. Maintain master copy & distribute control copy of documents to respective departments. Gain knowledge regarding medical device applications. Developing and implementing quality systems: Including policies, procedures, and guidelines, to ensure that products or services meet the required quality standards. Conducting audits and monitoring processes to ensure that they comply with quality systems and standards. Handling Customer Complaints Handling Corrective Action & Preventive Action (CAPA). Suggest & implement new document/ process/ system. Preferred candidate profile Should be a Graduate of Biological Science. (Bsc & Btech Biotechnology) Minimum 1 to 2 years of relevant experience required Certified internal auditor for ISO 13485;2016. Experience working with 3D printers in the healthcare segment. Strong organisational skills that reflect the ability to perform and prioritise multiple tasks seamlessly with excellent attention to detail.

Key Responsibilities: Manage pharmacy operations, staff, and inventory. Ensure CDSCO, PCI, and NABH compliance. Optimize medication therapy for pediatric and maternity patients. Drive budgets and tech-driven efficiency. Collaborate with doctors and nurses for patient care. Requirements: B.Pharm/PharmD with 8+ yrs hospital exp. (5+ yrs leadership). Maharashtra Pharmacy Council registration. Expertise in clinical pharmacy, GMP, and regulations. Strong leadership & communication skills.

Experienced in pharmaceutical RA labeling, cGMP/FDA/CFR compliance, SPL creation, proofreading, and DSCSA. Skilled in MS Office, Adobe, TrackWise, SharePoint, and graphic design. Knowledge of label lifecycle, drug listing, and patent carve-outs.

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Responsibilities : Verification and Validation: Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements. Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines. Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards. Analytical and Microbiology Methods: Provide expert review and oversight of analytical and microbiological testing protocols, data, and reports, ensuring compliance with regulatory standards and internal quality systems. Oversee the development, validation, and implementation of new analytical and microbiological methods and, including but not limited to chemical analysis, sterility testing, microbial limits testing, and endotoxin testing. Ensure that all methods are validated to provide reproducible and accurate results, adhering to FDA, TGA, ICH, and EMA requirements Data Review and Integrity: Conduct thorough reviews of raw data and final reports related to analytical and microbiology testing and method validation. Ensure that all data generated during analytical and microbiological testing is accurate, complete, and adheres to the approved protocols and SOPs. Identify and resolve any data discrepancies or deviations from established protocols. Regulatory Compliance: Ensure that all analytical and microbiological methods and validations comply with FDA, TGA, ICH, and EMA regulations. Assist in the preparation of documentation for regulatory submissions, providing quality assurance support for analytical and microbiological data and validation reports. Continuous Improvement: Contribute to the development and continuous improvement of quality systems related to analytical and microbiological methods and validation processes. Participate in root cause analysis of quality issues and support the implementation of corrective and preventive actions (CAPAs). Training and Development: Provide guidance and training to RD staff on best practices in analytical and microbiological testing, method validation, and quality assurance. Act as a mentor and resource for junior staff in the areas of analytical development, microbiology and quality assurance What youd gain: Invaluable hands-on experience working alongside seasoned developers. Opportunity to learn and grow in a supportive environment. Gain exposure to the entire software development lifecycle. Contribute to real-world software projects and make a positive impact. Qualifications: Bachelors degree in Chemistry, Microbiology, Biology, Pharmaceutical Sciences, or a related scientific discipline is required. Advanced degree (Masters or Ph.D.) in a related field is preferred. Minimum of 5-7 years of experience in quality assurance with a focus on analytical, microbiology, method verification, and validation within the pharmaceutical, biotech, or life sciences industries. Extensive experience with analytical and microbiological testing methods, including method verification, validation, sterility, microbial limits, and endotoxin testing. Strong expertise in analytical and microbiological methods and their application in product development. Excellent attention to detail and analytical skills with a focus on data integrity and accuracy. Strong written and verbal communication skills, with the ability to document and present complex technical information clearly. Ability to work effectively in a team-oriented environment and collaborate across multiple departments. Proficiency with quality management systems and software tools. This position is remote and may require occasional travel to other sites or meetings. The role may involve working in a laboratory environment with exposure to chemicals and biohazardous materials.

We are looking for an experienced Senior Implementation Specialist with deep expertise in the life sciences industry to lead and execute complex implementations of our technology solutions. This role requires a seasoned professional with over 10 years of implementation experience, strong technical knowledge, and a proven track record in the life sciences domain. The ideal candidate will ensure seamless deployment, integration, and optimization of Freya Fusion, managing both client expectations and regulatory requirements. Key Responsibilities: Project Leadership : Lead the end-to-end implementation of Freya Fusion, overseeing all phases from project scoping and requirements gathering to configuration, testing, and go-live. Client Relationship Management : Act as the primary point of contact for clients, offering expert guidance, managing expectations, and consistently maintain positive relationships to ensure successful adoption of Freya Fusion. Solution Configuration : Collaborate closely with technical teams to configure Freya Fusion according to client specifications, ensuring integration with existing enterprise systems and compliance with industry standards. Data Migration & Compliance : Manage and execute data migration strategies, conducting thorough data validation to ensure accuracy and compliance. Detailed Project Planning : Develop and maintain comprehensive project plans, including timelines, resource allocations, and milestones, while actively identifying and mitigating risks. Regulatory Compliance : Ensure all implementations meet global regulatory standards relevant to the life sciences industry (FDA, EMA, GxP, etc.), maintaining clear documentation for compliance and audit purposes. Client Training & Post-Implementation Support : Conduct training sessions, develop user guides, and provide continued support to clients to facilitate seamless onboarding and system adoption. Process Improvement : Collaborate with internal teams to continuously improve implementation processes, sharing insights to enhance client satisfaction and optimize solution delivery. Required Qualifications: Educational Background : Bachelors degree in Life Sciences, Computer Science, Information Systems, or a related field. Advanced degrees or certifications in Project Management (PMP) or Life Sciences regulatory standards are preferred. Extensive Experience : 10+ years of experience in software implementation (SAAS -Preferred), with at least 5 years focused in the life sciences industry (pharmaceuticals, biotech, MedTech, etc.). Technical Expertise : Strong background in implementing SaaS platforms in regulated environments; experience with Regulatory systems/tools in Life Sciences or similar RIMS or regulatory platforms is highly desirable. Project Management Skills : Demonstrated expertise in project management and handling complex, high-stakes projects, using tools like JIRA, Asana, or MS Project. Regulatory Knowledge : In-depth understanding of life sciences regulations and standards, including FDA, EMA, and GxP requirements. Exceptional Communication and Negotiation Skills : Outstanding client-facing skills with the ability to convey complex technical information to a diverse audience. Problem-Solving & Adaptability : Skilled at troubleshooting and resolving client-specific challenges with a flexible, solutions-oriented approach. Preferred Qualifications: Previous experience with SAAS platforms in Life Sciences or equivalent regulatory and compliance platforms. Proven track record in leading system integrations, data migrations, or configuration management in SaaS environments. Experience working within an Agile framework and Linear Framework

Chemical Testing: Perform chemical test like FTIR, NMR, GC-MS, and titration to analyze the chemical composition of polymer Data Analysis, Sample Preparation Knowledge of statistical analysis technique quality management system, such as ISO 9001 Required Candidate profile Bachelor’s degree in chemistry, Polymer Science, Chemical Engineering Strong understanding of polymer chemistry and materials science We have 2 vacancies – 1 Male & 1 Female candidate.

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products Oversee product lifecycle management from ideation to commercialization Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions Strong project management and UX design skills are required Knowledge of FDA and HIPAA regulations is a plus

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.

Oversee the entire quality assurance process, from raw materials to finished goods, ensuring consistent quality & compliance, ensuring that products meet regulatory requirements & quality standards like ISO 13485, ISO 9001, 21 CFR 211 & 21 CFR 820 Required Candidate profile Bachelors in science 10-15 years' experience in quality in medical device/ pharma industry QMS implementation experience Must have regulatory audit exposure Like WHO/ USFDA & EU GMP

Job Title: Senior Manager- Logistics Department: Logistics / Supply Chain Management Location: Vashi / Head Office Reports To: Logistics Head Job Description: We are seeking a highly experienced and motivated Senior Manager Logistics to oversee end-to-end international trade operations, including import/export logistics , regulatory compliance , and banking documentation . The ideal candidate will bring a deep understanding of DGFT, CDSCO, Customs, and global trade regulations. Key Responsibilities: Manage import/export logistics for raw materials, capital goods, and high-seas trade. Handle customs clearance , DGFT documentation , MEIS/RODTEP claims, and AD Code registrations. Coordinate with CHA agents , ports (JNPT, Sahar), and international banks. Ensure timely and accurate filing with regulatory authorities (CDSCO, FDA, PHARMEXCIL, IMC). Liaise with DGFT, CDSCO, GST, MPCB, RBI, FEMA and other regulatory bodies . Attend hearings and manage legal responses (customs, GST, ED disputes). Work with banks for LCs , bill discounting, foreign payments, and remittance documentation. Collaborate with internal teams (Finance, Purchase, Admin, QA/RA) for smooth logistics operations. Ensure accuracy and timeliness in quarterly filings, license renewals, and logistics reporting. Candidate Profile Experience: 5-10 years in international logistics, import/export operations, and regulatory compliance. Knowledge of: DGFT, CDSCO, Customs, RBI/FEMA, GST, MEIS/RODTEP schemes. Tools: ERP systems, MS Office, ICEGATE, DGFT & CDSCO portals. Skills: Leadership, Coordination, Documentation, Negotiation, Communication. Why Join Us? Be part of a leading chemical & pharmaceutical organization . Engage in challenging, cross-functional international operations . Work in a compliance-driven and growth-oriented environment . Apply Now If you're passionate about managing logistics operations and working in a high-impact role apply on Naukri or send your resume to hrd@calyxindia.com and become a part of the Calyx growth journey!

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships with stakeholders, associations, etc. through appropriate management of expectations and objectives, ensuring consistent and effective communication. Will handle the Invoicing, NFA, payment disbursement activities, etc. Draft representations, communication for various stakeholders. Additional Responsibilities: Supporting corporate communications efforts with different stakeholders. Monitoring key industry events and, ensuring ENGIEs participation at appropriate levels to enhance visibility and influence.

Lead the design and development of innovative digital health products. Oversee product lifecycle management from ideation to commercialization. Collaborate with healthcare providers and tech teams to ensure compliance with medical regulations. Must have experience in telemedicine, wearable tech, or AI-driven healthcare solutions. Strong project management and UX design skills are required. Knowledge of FDA and HIPAA regulations is a plus.