302 Cmc Jobs - Page 9

Syneos Health is looking for Regulatory Manager (CMC, EU & Japan/China) to join our dynamic team and embark on a rewarding career journey Collaborate with cross-functional teams to achieve strategic outcomes Apply subject expertise to support operations, planning, and decision-making Utilize tools, analytics, or platforms relevant to the job domain Ensure compliance with policies while improving efficiency and outcomes

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries....

Role & responsibilities Prepares the submissions (ANDAs, amendments, supplements including labeling, annual reports) to support commercial business and to be-in compliance to FDA regulations. Review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA. Escalate the review findings for a timely resolution. Leads labeling development for product launches and ensures that all labeling meets company and US regulating health authority specifications. Initiate/Review change control process and coordinate with other departments to ensure timely implementation. Prepare, review and submit eCTD submissions. Collab...

Career Category Operations Job Description As an Associate, Regulatory Data Management you will help ensure the compliance of our regulatory data via the smooth compliant flow of information across our systems and processes. Roles & Responsibilities: Provide support on maintaining our Regulatory Information Management (RIM) system. Create and archive clinical trial, marketing application submissions and health Authority correspondence within the organisation RIM system. Serve as a point of contact between regulatory representatives, CMC, safety, partners and the submission management team. Provide support on creating, running and analysing reports for data streamline projects. Provide suppor...

Job Vacancy Location : Padi, Mahindra World City & Madurai. Qualification : B.E (Mech) /Automobile. B.E (EEE), B.E (ECE) B.Tech (Mech) / Automobile B.Tech (EEE), B.Tech (ECE) Job Description Quality Control Engineer Looking for experienced Quality Control candidates with strong knowledge of PPAP and IATF 16949 documentation. Must be capable of handling customer complaints, root cause analysis, and corrective actions. Responsible for monitoring in-process and final product quality as per standards. Should have hands-on experience in quality tools and report generation. Ability to face and support internal/external audits independently. Join our team to ensure consistent quality and drive cont...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of t...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Sup...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...

We are looking for a highly motivated and results-driven Customer Sales Executive to join our team in Hubli. The ideal candidate will have 2 to 7 years of experience in sales, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products with the guidance of the Supervisor/Man...

We are looking for a highly motivated and customer-focused individual with 0 to 3 years of experience to join our team as a Customer Service Executive in Coimbatore. The ideal candidate will have excellent communication skills and the ability to work effectively in a fast-paced environment. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager, including identifying potential business customers. Collect and validate customer documents according to organizational norms. Log cases in the system following SOPs and processes for disbursement. Fulfill sanction ratios as per organizational requirements. Meet customer needs and cross-sell multiple products with the hel...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Guwahati. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Super...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Superv...

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Nagpur. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the...

The incumbent will be responsible in an individual contributor role for supporting analytical research and development activities (method development, validations, transfers, documentation, stability, etc) for API and drug products. The candidate will be responsible for supporting multiple projects and will work in close collaboration with partner groups across the organization such as global development teams (formulation, chemistry, API scale up, etc), regulatory, quality, manufacturing and clinical organizations as we'll as manage analytical activities outsourced to vendors. The candidate will be responsible for authoring and reviewing various documentations such as specifications, test p...

Berger Paints India Ltd ( British Paints Div ) is looking for Area Sales Manager - Prolink 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 whi...

Job Description Review of CMC related documents received from various inter functional departments and provide necessary inputs as per regulatory requirements. Preparation of CMC sections, compilation and review of dossiers as per country specific requirements. Track collection of all dossier/information from all concerned departments and ensure submission to regulatory authorities as per the agreed timeframe. Responsible for regulatory impact assessment in QAMS (Lupin biotech, Ghotawade facility). Responsible for preparation and compilation of query responses by coordinating with inter-function teams and submit to regulatory authorities within stipulated timeline. Continually track any chan...

Implement and maintain SAP BusinessObjects (BO) solutions, focusing on report generation, dashboard development, and data visualization. Ensure accurate data representation and enhance decision-making processes for business users.

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 ...

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Experience Level: 4 to 6 Years Qualification: B.E., Electrical / E&TC Work Location: Pune Notice Period: 30 days Candidate should have experience in development of electronics components like PCB, Cell Module controller (CMC) and High voltage/ Low Voltage connectors. I have attached JD for your reference. Job Description: Roles & Responsibilities: Development of Cell module electronic components like connectors, Cell module controller etc. Voltage, Current, Resistance calculations for development of busbars and HV components. Electric layout design of the cell module. Coordination with the supplier and cross functional teams for development of electronic connectors. Clearance and creepage ca...

Christian Medical College is looking for Project Co ?? Ordinator / Junior Research Fellow / Senior Research Fellow for the Department of Clinical Haematology (Job Code-1603 ) to join our dynamic team and embark on a rewarding career journey Research Support: JRFs work under the guidance of senior researchers or principal investigators on research projects They assist in conducting experiments, data collection, literature reviews, and data analysis Data Collection and Analysis: Collecting and recording data from experiments or research studies and using appropriate software or statistical tools for data analysis Literature Review: Conducting comprehensive literature reviews to understand the ...

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility 1. New submissions: a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. b. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. 2. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. 3. Lifecycle management for drug formulations: a. Prepare and review variation , ...

Role & responsibilities Please find your responsibilities and job description as under: 1. Handling Purchasing of Services (e.g. AMC/CMC, Calibration of Equipment & PT Participation) and Supplies (e.g. Lab Equipment, Chemical & Consumables). 2. Handling purchasing of Capex requirements. 3. Planning and budgeting of purchase functions, involving cost estimation, contract negotiations. 4. Collecting Data for Monthly requirements from all departments (including chemicals, Glassware, stationary and all related things required in lab), merging all data, taking approval. 5. Managing and coordinating for lab Purchase including chemical, glassware and for any other lab related activities 6. Follow u...

Find a Career With Purpose at Teva Keyword Location Select how often (in days) to receive an alert: Regulatory Affairs Associate III- RA CMC Lifecycle EMSO APAC Date: Jun 18, 2025 Location: Navi Mumbai, India, 400706 Company: Teva Pharmaceuticals Job Id: 62484 Who we are How you ll spend your day Assessment of change controls for registration impact and implementation of all necessary dossier changes; specifically for Europe and International Market. Responsible for compilation of the variations, renewals, RFI responses for the products in the product portfolio in collaboration with other stakeholders. Responsible to keep trackers and database up to date. Briefing the regulatory status in di...