302 Cmc Jobs - Page 11

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability - the Elanco Healthy Purpose - to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you ll be part of a company that values and champions new ways of thinking, work ...

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. 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 lifecy...

Responsibilities: Submission support: Submission management support for MRP & DCP procedures, PSUSA submission, Renewals, Repeat use procedures, variations etc. Preparation and compilation of regulatory documentation for the registration, variation and renewal of OTC drugs for EMEA. Prepare cover letter, application form and relevant Module 1 documents for variations. Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing. Work with regulatory team to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. Regulatory review of submission documents for compliance. Work with cros...

JOB DESCRIPTION Designation Field Service Engineer /Service Engineer Department One GW Service Modality GE Ultrasound Relevant Work Experience Freshers - Minimum 5 years Languages to know - Kannada & English 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 CMCs sales on time with excellent customer rapport will be the key drivers of initial success in this role. Key Responsibilities to Deliver (Daily, Weekly, Monthly, Quarterly, An...

Summary Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle. About the Role Major accountabilities: Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System Ensure CMC document...

Wte Infra Projects Pvt Ltd 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...

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inc...

Main Responsibilities Sourcing Expertise & experience in CDMO/CMC/Chemistry/Toxicology Exposure to import of Specialty chemicals from China Extensive experience on Cost Sheets. Experience in import and its related formalities to ensure timely clearances and delivery of imported Goods (Lab equipments and chemical/consumables) Procurement of Biologicals & Consumables Liaison with Regulatory Authorities Develop, lead and execute purchasing strategies. Track and report key functional metrics to reduce expenses and improve effectiveness. Craft negotiation strategies and close deals with optimal terms. Partner with stakeholders to ensure clear requirements & documentation. Forecast price and marke...

Hi We are Hiring for the job role of Medical Writer Job Description: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinic...

Develop and implement regulatory CMC strategies to support post-approval changes (PACs), variations, and life cycle activities in Europe, UK. Lead the preparation, review, and submission of high-quality regulatory CMC documentation. Act as the primary regulatory liaison for CMC topics with internal stakeholders (e.g., manufacturing, quality, supply chain, R&D) and external partners (e.g., CMOs, CROs). Monitor and interpret global regulatory requirements and industry trends related to CMC and life cycle management. Ensure regulatory compliance of CMC activities through robust planning and documentation in alignment with ICH guidelines and regional regulations. Lead or support meetings and int...

Experienced in documentation (pharma companies) and negotiation. Person should know Documentation, reviewing, complying from the scratch. A person who prepares, controls and authors CMC documentation. CMC : Chemistry manufacturing and control Involved in Drug launch The person should know end to end process. Like involving with R&D team/plant etc. Coordinate and deliver the process seamlessly. License renewal Experienced in getting pre-approval and post- approvals with authorities with different countries. Good prior experience in authorizing dossiers in US, UK market. Or emerging market like Africa. ROW - rest of the world market Proficient/Good working experience in Veeva tool. Should have...

Apollo Pipes Ltd 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 products an...

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality 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...

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 devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects. Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects. Communicate with clients and Health Authorities in close cooperation with the respective lead. Support with the planning and execution of client projects in accordance with KPIs in close ...

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Man...

Reporting to Sr. Director - Regulatory Affairs Experience required: 5-8 Years Education: B. Pharm / M. Pharm Department: Regulatory Affairs Key Responsibilities: Prepare the status of all documents related to submission. Compile and review Regulatory submission documents required in line with the relevant guidelines. Coordinate with all stakeholders of the manufacturing plant for the collection of documents. Evaluation of change control: evaluate all post-approval changes. Review of specifications (API, Intermediate, FP, and Shelf life) executed BMRs, BPRs, COA, Method transfer report, Method verification, Analytical chromatograms intended for regulated or non-regulated market submission. Ge...

Summary The Technical Project Leader will, jointly with the CMC team, lead and manage all technical development activities for assigned small molecule projects within Technical Research Development (TRD); represent TRD as core member in global project teams to define the global CMC strategy for the development, submission, approval and life cycle management of a product(s); maximize the support to local programs and partners; lead CMC teams with strong strategic focus, quality environmental awareness, management capabilities, scientific and technical expertise; act as the TRD representative in complex projects involving external partners and/or highly innovative projects/processes. About the...

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any con...

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality a...

-Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches. Major accountabilities: Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Identify the required documentati...

Supporting product maintenance, and activities throughout the product life-cycle using regulatory strategies and documents related to CMC (Chemistry, Manufacturing Control). This applies to sector-specific (global and local) products and is intended to ensure timely market supply in compliance with regulatory requirements. Supporting change - and inspection management within the QA Compliance Team. Key Responsibilities: Maintaining close cooperation with RA CMC to discuss regulatory requirements, strategies and knowledge of global product dossiers to stay up-to-date. Conducting training to ensure appropriate knowledge and regulatory compliance. Supporting the area in effective change control...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Career Category Regulatory Job Description 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 sc...

Truhome Finance is looking for Branch 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 products a...