302 Cmc Jobs - Page 10

Description. Sr Regulatory Consultant (Biologics/Biosimilars). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with pass...

Senior Demonstrator (NM) for the Department of Immuno Hematology and Blood Transfusion Qualification: M.Sc. in Medical Lab Technology Experience: Candidates applying for Senior Demonstrator (NM) post should have completed 4 years as Demonstrator (NM) in CMC. Coordinate the BSc MLT course and also provide laboratory diagnostic services. Job Preference: Worked as AHS Course Coordinator for a minimum of 3 years in an academic institution. Salary: As per institutional Rule Accommodation not Provided 21/06/2025

Sona BLW Precision Forgings Limited Job Description JD Code QTY12 Department Quality Designation Engineer / Sr. Engineer Reports to DGM In Process Quality Qualification BE (Mech/EEE) Preferred industry Automotive Industries Experience 5-8 years Location Chennai JOB DESCRIPTION Job Purpose: In-process Quality Key Accountabilities / Responsibilities: Do process Audit Basic understanding of Processes Verification for APQP and PPAP elements Interpretation of Drawing and ES. Problem solving using 8D Perform DOE to understand variation, and resolve dispute. Documentation to confirm to TS 16949 Handling of measuring instruments, and use of first principle measurement techniques. Effective written a...

Key Responsibilities: Preparing and submission of Sterile Finished Product application CT-10, CT-12, CT-16, CT-21, Form-30, Free sale certificate, Certificate of Pharmaceutical Product, WHO-GMP. Endorsement of Sterile product under the manufacturing licence. Licensing to State drug controller & for getting the licence within a time period given by management. Submission of IND & NDA application of biological products (Cell lines/Tissue Engineered products) Compilation & review of Dossier according to CTD Modules (Module -1,2,3,4 and 5). Review the CMC documents of new product development. Compilation and review of Medical device(s)- Device Master Files. Preparation of the dossier as per chec...

Responsible for developing and implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of all regulatory milestones for moderate to less complex projects through the product lifecycle including assessment of the probability of regulatory success together with risk mitigation measures. Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Lead execution of CMC documentation including IND/CTA, NDA/BLA/MAA, postapproval ...

Role & responsibilities Revenue Management: Develop and implement strategies to meet or exceed service revenue targets for AMC, CMC, spares, spot visits, PM kits, QC kits, and consumables. Analyze market trends and customer needs to identify new revenue opportunities and enhance existing service offerings. Commercial Operations: Oversee all back-office operations related to commercial activities, including invoicing, payment processing, and collection. Streamline processes to improve efficiency and accuracy in billing and collections. Ensure compliance with regulatory requirements and company policies. Cross-Functional Collaboration: Work closely with sales, marketing, finance, and technical...

Sona BLW Precision Forgings Limited Job Description JD Code QTY12 Department Quality Designation Engineer / Sr. Engineer Reports to DGM In Process Quality Qualification BE (Mech/EEE) Preferred industry Automotive Industries Experience 5-8 years Location Chennai JOB DESCRIPTION Job Purpose: In-process Quality Key Accountabilities / Responsibilities: Do process Audit Basic understanding of Processes Verification for APQP and PPAP elements Interpretation of Drawing and ES. Problem solving using 8D Perform DOE to understand variation, and resolve dispute. Documentation to confirm to TS 16949 Handling of measuring instruments, and use of first principle measurement techniques. Effective written a...

Our team members are at the heart of everything we'do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead. Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical d...

? ?Job Description ?As a Support consultant it consists maintenance activities of the developed reports and projects. -Maintenance of BI launchpad CMC -Resolving the issues/incidence came from the business in the developed project and reports -All the admin activities and managing CMC(central management console) -Maintenance and checking server and server groups -Managing security profiles. -Upgradations, migration activities related to the system. -Managing folders, documents, reports, dashboards, connections, web services and universe in repositories. -Create User access levels and provide the access to users -Managing BOBJ License

Job Summary: We are seeking a Regulatory Affairs Specialist with 4 to 8 years of experience in compiling, preparing, and submitting regulatory dossiers in accordance with European regulations (EMA/EU). The ideal candidate will have a proven background in injectable drug products and will ensure regulatory compliance throughout the product lifecycle, working closely with cross-functional teams and regulatory agencies. Key Responsibilities: Prepare, compile, and review regulatory submissions for the EU region, including CTA, MAA, Variations, Renewals, and PSURs/DSURs. Ensure dossiers comply with EMA and national regulatory authority requirements, including eCTD/NeeS formatting. Maintain produc...

CirrusLabs Private Limited is looking for SAP BO Developer to join our dynamic team and embark on a rewarding career journey Requirements Gathering: Collaborating with business users and stakeholders to understand their reporting and analytics requirements You gather and document functional and technical requirements, ensuring a clear understanding of the desired outcomes Design and Development: Designing and developing SAP BO solutions based on the requirements This includes creating universes (semantic layer) that define the business logic and data relationships, building queries, and designing reports and dashboards using SAP BO tools such as Web Intelligence, Crystal Reports, and Dashboa...

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.

About your role We have vacancy for CMC expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. This individual will be based in Mumbai. The candidate has the possibility to utilize his/her own strengths with the support of the professionals. Your key responsibilities Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents in CTD and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work) To prepare response to regulatory deficiencies letters according to EU regulator...

The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management ...

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site...

Let’s do this. Let’s change the world. In this vital role you will report into the Regulatory Compliance Team lead. 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 Manager include: Reviews change records to evaluate impact of the change with res...

Interested candidates share resume to sanjay.behera@thyrocare.com or whatsapp to 8928285213 Freshers can apply Administrative Duties: Oversee daily administrative operations of the lab facility. Coordinate procurement of office/lab supplies and maintain inventory. Manage service contracts, AMC/CMC for lab equipment and utilities. Vendor coordination and negotiation for services and repairs. Documentation and maintenance of facility-related records. Handle visitor management and front-desk support, if required. Electrical Maintenance: Perform routine checks and preventive maintenance of electrical systems (UPS, HVAC, panels, generators, etc.). Troubleshoot and repair minor electrical issues p...

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : SAP UI5 Development Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for ensuring that the applications are developed according to specifications and delivered on time. Your typical day will involve collaborating with the team to understand the requirements, designing and dev...

Dossier Power House

Christian Medical College is looking for Staff III Critical Care Therapist to join our dynamic team and embark on a rewarding career journey Assessment and Evaluation:Conduct comprehensive assessments of clients' emotional, psychological, and behavioral concerns Administer and interpret standardized assessment tools to gather relevant information Collaborate with clients to identify their strengths, challenges, and goals Analyze assessment results to determine appropriate therapeutic interventions Treatment Planning and Implementation:Develop individualized treatment plans based on clients' needs, goals, and diagnosis Select and implement evidence-based therapeutic interventions and techniqu...

JOB DESCRIPTION Position : Manager/Senior Manager Job Location : Gurgaon Education : M. Pharm Department : Global Regulatory Affairs Job Responsibilities Serve as a Regulatory CMC Product Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded being developed for US and other advanced markets like EU & Canada Ensure lifecycle management through timely submission of annual reports, supplements etc to ensure product continuity The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products in which responsible including assessment of the probability of regulatory success together with r...

Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effect...

Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contacting Old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental Finalizing quote with Customers and converting it into the PO. Timely Customer complaints resolutions and effect...

Senior Service Engineer Job Details | Ingersoll Rand Careers Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Service Engineer Chennai, TN, IN, 603 002 Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division & part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilit...

Senior Service Engineer Job Details | Ingersoll Rand Careers Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Senior Service Engineer DL, IN, 110064 Job Title Sr. Service Engineer Location NASH Pune plant/Delhi/Chennai About Us GD NASH is a part of Ingersoll Rand engineered solutions division & part of PFT. We are market leader in Centrifugal Blowers and Liquid Ring Vacuum Pumps Job Summary The engineer will be responsible for handling Warranty and out of warranty Service issues in Centrifugal blowers, Liquid Ring Pumps. He will be responsible for installation activities and earning Service Revenues(like AMC/CMC/Rentals). Responsibilities Contac...