302 Cmc Jobs - Page 12

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...

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 company€™s 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 produc...

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.

Role & responsibilities :- 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. P...

The purpose of this role is to be responsible for the regulatory CMC activities for new registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products within the category and in particular the regulatory CMC strategy of new product developments and major CMC changes. Incumbent may oversee specific elements of internal compliance processes and ensure best practices are in place aligned to KPIs. The CMC Senior Manager may mentor a team of manager(s) and/or associate(s); in that case, he/she would have the overall accountability of the portfolio supported by the team. The CMC Senior Manager may be a Subject Matter Expert, bringing in the role an...

The Senior Associate, Global Submission Management – Americas, 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 North American 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 and Regulatory submissi...

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery de...

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role is for a technical functional lead/developer with Clinical Risk Based Monitoring (RBM) / Risk Based Quality Management (RBQM) system implementation. The role involves working closely with product managers, designers, and other engineers to build high-quality, scalable software solutions. Roles & Responsibilities: Participate in technical discussions related to the RBSE system(s) within Clinical Trial...

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. ...

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...

The RA CMC Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. Key Activities Contributes to product teams and acts as product lead or ...

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions

Responsibilities: Work with the regional RA team to prepare documents for the registration of OTC drugs and cosmetic products in non-EU countries. Provide regulatory support for select projects such as artwork maintenance and artwork support for legal department and other special projects on an as needed basis using a variety of systems internally Preparation and compilation of regulatory documentation for the registration and renewal of OTC drugs and cosmetic products for EMEA and local pool Support product registration in all EMEA regions including Nordics and Northern Cluster Manage regulatory action item (task) tables including mapping, coordination of regulatory inputs, and timing Work ...

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 13 yrs Work Location :Bangalore/Hyderabad/Pune/Chennai/Kolkata Required Skills, SAP BODS Interested candidates can send resumes to nandhini.spstaffing@gmail.com

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :4 to 6 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Warm Greetings from SP Staffing!! Role: SAP BODS Experience Required :5 to 8 yrs Work Location :Bangalore Required Skills, SAP BODS Interested candidates can send resumes to nandhini.s@spstaffing.in

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Roles and Responsibilities Review of technical regulatory documents for drug substance and drug products Compilation of CMC data for submission to regulatory authorities Review and approval of master documents for CMC segments Preparation and review of annual reports, amendments, supplements etc. Assist with CMC responses to regulatory authorities queries during development, registration, and product lifecycle. Evaluation and co-ordination of change controls Liaison with various departments like R&D, QC, QA, Production, stability departments for obtaining documents. Prepare response to regulatory deficiencies letters according to US regulatory requirements. Desired Candidate Profile The cand...

Job Context: To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities. Challenges: 3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role) Revenue / Operating Budget As per JDI RA budget plans Geographical Responsibilities (Global / International / Country / Area with in Country Will work with the team in Canada and based out of India Area of Impact (Dept. Location / Function or B...

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 ...

Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement

Role & responsibilities : Install configure and upgrade SAP BO environments BI 4x. Manage BO servers services and clusters including CMS FRS and Web Intelligence. Monitor system performance and availability implement tuning and optimization. Administer user access roles and security policies using CMC and CCM. Develop and maintain Universes using IDTUDT. Schedule and manage reports and dashboards WebI Crystal Reports. Troubleshoot and resolve issues related to BO tools and reports. Implement and manage auditing logging and alerting mechanisms. Collaborate with developers analysts and business users to support reporting needs. Perform backup and recovery of BO content and configurations. Docu...

Designation Field Service Engineer Department Service Location Delhi NCR, Pune , Raipur/Bhopal Product Portfolio IVD (In-Vitro Diagnostics) Business Importance of the Role: This role owns delivering service & service business results as per Operational Metrics defined below & meets the operating Business Plan of Genworks. Manages high level of Customer satisfaction through Service Excellence at assigned customer accounts/IB by driving various Operations parameters as per target. Also drive Commercial excellence through AMCs, CMCs, Part Sales, Accessories & Consumable Business time to time. Over a period of time becomes the Customer success leader & be the Point of contact by building strong ...

Job Summary We are looking for an experienced SAP BO Developer to design, develop, and support Business Intelligence solutions using the SAP BusinessObjects suite. The ideal candidate will have hands-on experience in BO reporting tools, strong SQL/data modeling skills, and the ability to collaborate with business and technical teams to translate requirements into insightful and actionable reports. Key Responsibilities Design, develop, and deploy reports, dashboards, and universes using SAP BO tools (Web Intelligence, Crystal Reports, IDT/UDT, BO Dashboards). Gather and analyze reporting requirements from business stakeholders. Build and maintain semantic layers using Universe Design Tool (UD...