298 Cmc Jobs

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

Role & responsibilities We have opportunity in Regulatory Affairs for Emerging Markets Position: Officer/Executive/Assistant Manager Regulatory Affairs Experience: 3-6 Years and 8+Years for Assistant Manager Qualification: B.Pharm/M.Pharm Location: Ahmedabad 1. Compilation of dossiers in CTD, eCTD & national formats 2. Compilation and submission of Queries Response and Variation Filing. 3. Review of documents, artworks 4. Review of change controls 5. Gap analysis for new product filing 6. Maintaining product Life cycle Candidates having experience LATAM/CIS/ Africa/Asean or any other Emerging Markets can apply

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

: - Visit the customers for attending to technical jobs viz., repairs, refurbishing etc. - Work as per contracts GMC / PMC / CMC schedules - Support the service business by generation of sales of genuine spares - Customer satisfaction by fast response and quick service (minimum lead time) for long-term relationships. - Salvage the spare parts, understand recurring problems of the products,replacement of spares at customers site and sending back items under warranty to HO for proper accounting and documentation. - Provide training to customers operators about upkeepment, maintenance and safety of the equipment purchased by the customers - Educate and recommend to the customers on new products...

Provide technical support, troubleshoot issues, & ensure customer satisfaction Perform preventive maintenance, document service activities, & coordinate with the sales team Manage AMC/CMC contracts, ensure customer satisfaction. Required Candidate profile Minimum of 2-3 years of experience in servicing IVD instruments or similar medical devices Strong technical skills in instrument installation, troubleshooting & maintenance.

: - Visit the customers for attending to technical jobs viz., repairs, refurbishing etc. - Work as per contracts GMC / PMC / CMC schedules - Support the service business by generation of sales of genuine spares - Customer satisfaction by fast response and quick service (minimum lead time) for long-term relationships. - Salvage the spare parts, understand recurring problems of the products,replacement of spares at customers site and sending back items under warranty to HO for proper accounting and documentation. - Provide training to customers operators about upkeepment, maintenance and safety of the equipment purchased by the customers - Educate and recommend to the customers on new products...

We are looking for a highly skilled and experienced professional to join our team as a Reg Associate Manager I Product Variations in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in product variations and regulatory affairs, with excellent analytical and problem-solving skills. Roles and Responsibility Manage and oversee the development of product variations, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to ensure timely and successful product launches. Develop and implement strategies to optimize product portfolio management and profitability. Conduct thorough analysis of market trends and competito...

Responsible for regulatory activity related to clinical section for US, ;EU, WHO, Canada, Australia, New Zealand and South Africa Markets Preparation of bioequivalence related sections of ANDA product dossiers as per current regulatory guidelines Ensure timely preparation of amendments related to bioequivalence to expedite approvals Review of BE protocol for all market including ROW market Review of bio-waiver information and clinical strategy before start of clinical study. Confirmation of reference product for EU countries for clinical study Review and Preparation of 2.4 (non-clinical review) and 2.5 (clinical review) module for EU submissions Review of SmPC, PIL, Labeling for US, EU and o...

Job Category: Biomedical Engineer Job Type: Full Time Job Location: Bangalore Qualification: BSBME or B.S. in BME Experience: 0 to 1 Year Asset Tagging and Tracking. Supervision & Management of Breakdown Maintenance (Repair)-same to be documented. Warranty Management/Preventive Maintenance. Providing User Training program. Maintaining the records of the documentation related to Biomedical Department like Service Reports, AMC/CMC Documents, Installation Reports & Calibration Reports. Maintaining the Equipment Condemnation List. Keeping Track of the Oxygen Cylinders across the Centres. All new Equipment/Spares/Accessories purchase to be taken prior Approval Keeping Track of the Rental Equipmen...

You will also drive continuous improvement by enhancing CMC regulatory processes, policies, and systems while serving as a Subject Matter Expert and Technical Dossier Approver. As a mentor, you will help onboard and develop new team members, fostering a collaborative and high-performing environment. Success in this role relies on strong cross-functional collaboration with teams such as Global Regulatory Leads, GSC, MSAT, QA, LOCs, and ESQ to define and implement effective regulatory CMC filing strategies. Key Responsibilities: Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to suppo...

Skills: "Industrial Hydraulics", "Hydraulic Power Pack", "Hydraulic Circuit", "Mobile Hydraulics" "Pneumatics", Yuken, Hydac, Parker, Veljan, Danfoss, Eaton, Atos, Bucher, (Employed in Direct Brand or their Dealer), Hydraulic PumpsHydraulic MotorsTorque HubsValvesManifoldsPower UnitsCylindersAccumulatorsJoysticksFoot PedalsSpare Parts, Experience in Service sales, Concept of AMC & CMC Contracts, Analytical and conceptual capabilities, Experience in AUTOCAD, MS word/ EXCEL; Presentation skills,. Industry:Engineering. Location and no. of position:. Kolkata (areaWB)01. Guwahati (areaNorth East)01. Benefits:PF, Cashless Medical Insurance at all top Hospitals for Full Family. Qualification:Diplom...

Skill requirement: Primary Skill -- Business Object 4.2 (Developer and Administrator), Web Intelligence / Crystal Reports, Universe design, CMC, CMS and Oracle PL/SQL Secondary Skill -- Windows, Unix scripts, Agile methodology Experience 6 to 9 years JD: To participate in report server configuration / upgrade and other SDLC activitiesincluding testing , deployment and support To be able to write new BO reports or modify existing BO report and also work along with other developers To manage the testing team for unit testing, system testing, integrated testing, UAT etc., To write the technical specification, functional specification, test plans and test scripts To coordinate with other team li...

Staff III Medical Lab Technician for the Department of Immunohaematology & Blood Transfusion Qualification: H.Sc., with Diploma in Medical Lab. Technician recognized by the CMAI or CMC DMLT and those who have completed 4 years of experience as Medical Lab Technician (Term Appointment) or equivalent only need to apply. Salary Scale : Rs.12762 - 510 - 25512 + DA & HRA as per rules. Age Limit: Below 35 years Note: Only Regular mode will be accepted, Private or correspondence will be not accepted.

Job Details Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communication with clients and Health Authorities. Support with scientific advice procedures and representation of clients with health authorities. Responsible for the planning and ...

Role Overview: You will be a Health Operations Associate Manager at Accenture, embedding digital transformation in healthcare operations end-to-end. Your role involves driving superior outcomes and value realization today, while enabling streamlined operations to serve the emerging health care market of tomorrow. As part of the Healthcare Management team, you will be responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes overseeing day-to-day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public...

Handled ANDA submissions with thorough knowledge on review of CMC documents of dosage: Injectables (simple and complex), Ophthalmics, Topicals, Nasal Sprays and Tablets. knowledge on Module 5 requirements with review & upload study reports. Required Candidate profile Experience of eCTD tools - Educe/Lorenz and/or Pharma Ready. evaluate and respond Agency’s Deficiencies. review DMF. USFDA. Experience of handling submissions related to site transfer products

Designation Field Service Engineer Department Service ONEIVD Modality IVD & GWSO Portfolio Focus Clinical Chemistry, Immunoassay, Haematology, Bio Chemistry POCT, Urine Analyzer Work Location Kannur, Trivandrum, Trichy & Hyderabad Reporting To Cluster Manager/Circle Manager - Service Relevant Work Experience Needed Fresher / Minimum 1yrs in IVD Service Budget CTC 2.66LPA - 3.5LPA Business Importance of the Role: This role owns and drives service business results as per the operating plan of Genworks IVD solutions, manage high level of OEM & Customer satisfaction through Service Excellence at cluster level. Setting up a new service repair center and drive consumables, accessories, AMC and CMC...

Role Overview: As a Customer Service Associate at Accenture, you will be a part of the Healthcare Management team responsible for embedding digital transformation in healthcare operations. Your role will involve driving superior outcomes and value realization in healthcare services today, while also preparing operations to serve the emerging healthcare market of the future. Your primary responsibilities will include coordinating essential documentation for global applications and managing electronic submissions related to Life Sciences Regulatory Operations. Key Responsibilities: - Coordinate essential documentation and resources required for filing global applications - Manage and process e...

In this role at Kyowa Kirin Group, you will be part of a team that focuses on Health & Productivity Management, with the goal of promoting good health, quality, and well-being for all employees. As part of our mid-career recruitment process, we kindly request that all applicants meet the following essential requirement: - Nonsmoker Please note that reapplication for the same position within one year is generally not allowed. The company operates under the name CMC, with the following details: - Address: 100-0004 92 - Working hours: 9:00-17:40, 8:00-16:40, 8:30-17:10, 9:00-17:40 - Contact numbers: 212/291/3 125, SPI 194971, 2008101, 201971 - Financial figures: 26,745 as of December 31, 2022, ...

Jr. Graduate Medical Lab Technician (Term Appointment) for the Department of Clinical Virology (CMC Vellore, Ranipet Campus) Qualification: B.Sc. MLT. Preference: to those who have 4 years of experience in CMC (After 2020) Accurate and timely analysis of samples. Technical staff are expected to do shift duty, entry of Data and registration in the computer is needed.

SAP Security JD: 10+ Years of Security implementation/support experience. Should be expert in ECC security (SU24 setups, end to end role build & other troubleshooting skills). Should be proficient in BW security (Analysis Authorization based access provisioning). Good to have: SAC, BTP, IBP knowledge. GRC Support knowledge. CRM, Fiori, CMC, BODS/BOBJ Security

Kotak Mahindra Bank Limited is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new p...

Description: Mandatory Skills:(MUST HAVE SKILLS) Experience with design and development of SAP Fiori, UI5 applications Experience with the SAP CAP framework, Fiori Launchpad, SAP BTP and its services especially workflow, Cloud Foundry and Kyma Experience with the OData API for SuccessFactors is a plus Strong analytical skills, personal drive and ability to deliver quality work IT Software Development or similar background and have several years of experience working in an international organisation with a complex IT environment... Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade :C Level :To Be Defined Named Job Posting? (if Yes - needs to be approve...

1. Able to attend to all mechanical-related works. 2. Should be able to handle the breakdowns with the team and individually. 3. Awareness of Hydraulics, Lubrication, and Other Oils (like Engine, Transmission, etc.). 4. Awareness of fasteners, weld joints, and pipeline routing. 5. Awareness of electrical-related works. 6. Awareness of EMS, QMS, and OSHAS Documentation. 7. Awareness on 5S Implementation and Guidance to Supervisor and below. 8. Able to complete the preventive maintenance according to the schedule. 9. Awareness of the Pneumatic and Hydraulics Symbols. 10. Liaison with other departments. 11. Awareness of safety precautions while working on mechanical works. 12. Should follow up ...

2. Should be able to handle the breakdowns with the team and individually. 3. Awareness of Hydraulics, Lubrication, and Other Oils (like Engine, Transmission, etc.). 4. Awareness of fasteners, weld joints, and pipeline routing. 5. Awareness of electrical-related works. 6. Awareness of EMS, QMS, and OSHAS Documentation. 7. Awareness on 5S Implementation and Guidance to Supervisor and below. 8. Able to complete the preventive maintenance according to the schedule. 9. Awareness of the Pneumatic and Hydraulics Symbols. 10. Liaison with other departments. 11. Awareness of safety precautions while working on mechanical works. 12. Should follow up on the logbook records, like oil consumption, daily...