299 Cmc Jobs - Page 4

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...

Description Regulatory Consultant (CMC/ EU Market Exp) Syneos Healthis 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, youll collaborate with passionate problem so...

Job Description: 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 lifecycle...

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...

Trade Finance Center will be responsible for completing all the part within the TAT with 100% accuracy in processing They are required to check all the relevant documents properly before processing The team will also be responsible for mentioning the rejection comments for rejection cases in one shot for avoiding delay in processing Ensuring comprehensiveness of PMC / CMC proposals being placed for approval to PMC / CMC Committee by the department / unit Preparation & circulation of PMC/ CMC dashboard to business unit on Weekly basis Following up with business units for PLD and self certification pendency Attending CGA mails and taking necessary action by providing Process Master Process flo...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products • Collaboration with partners to develop and execute global regulatory activities • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier p...

Role Overview: You will be responsible for initiating, reviewing, and approving various quality management systems such as Change Controls, Deviations, Investigations, CAPA, OOS, and Complaints. In addition, you will handle Return Goods and ensure the proper functioning of the quality system by performing risk assessments as needed. Conducting regular internal audits will also be part of your duties. Key Responsibilities: - Review and approve all documents including SOPs, Spec & STPs, Forms, protocols, and reports to ensure compliance. - Review annual product quality review reports and provide training on cGMP topics to employees at the site. - Support customer audits/visits and regulatory a...

Role Overview: As the Regulatory Manager (CMC, EU & Japan/China) at Syneos Health, you will play a crucial role in a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The focus of the organization is on translating clinical, medical affairs, and commercial insights into tangible outcomes that address the realities of the modern market. In this role, you will have the opportunity to engage with the vast experience of Syneos Health, contributing to the collaboration on a significant percentage of Novel FDA Approved Drugs and EMA Authorized Products. Key Responsibilities: - Collaborate with a team of enthusiastic problem solvers to ass...

Greetings!!!! We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre. Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes. Key Responsibilities: Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions. Responsible for filing supplements : CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates. Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines . Strong interpretation of FDA queries and drafting of high-quality responses. Review and preparati...

GC, HPLC, UV, Malvern, LCMS | SOPs, MSDS, COA | 5S, NABL, GLP, IMS | Reports | Impurity Profiling Inventory, AMC, CMC & LIMS management. Monthly/Yearly report preparation. Audit exposure

As a Regulatory Affairs Consultant - Head, you will leverage your minimum of 10 years of Life Science industry experience to provide substantial expertise in regulatory affairs. Your hands-on experience in Chemistry, Manufacturing, and labeling processing will be crucial in ensuring compliance with global regulatory standards such as FDA, EMA, ICH, and other international regulations. Your excellent communication skills, both written and verbal, will be essential in effectively conveying regulatory requirements within the organization. Key Responsibilities: - Demonstrating expertise in CMC and labeling processes - Ensuring compliance with global regulatory frameworks including FDA, EMA, and ...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products • Collaboration with partners to develop and execute global regulatory activities • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier p...

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

The CT Scan Service Engineer will be responsible for installation, preventive and corrective maintenance, calibration, and troubleshooting of CT Scan equipment. The role ensures uptime, safety compliance, and smooth functioning of imaging equipment, while delivering technical support and service excellence to hospitals, diagnostic centers, and healthcare providers. Key Responsibilities: Install, configure, and test CT Scan machines as per manufacturer standards. Perform preventive maintenance, calibration, and performance checks to ensure equipment reliability. Diagnose and troubleshoot breakdowns, technical faults, and system errors. Coordinate with OEMs/vendors for spare parts, software up...

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinat...

We're Hiring: Regulatory Affairs CMC Associate Location: Navi Mumbai Years of Experience:4+ years Work from Office Notice Period: Looking for immediate joiners Skills Required: Bachelor's or Master’s degree in Pharmacy, Chemistry, Life Sciences, or a related field. 4+ years of experience in Regulatory Affairs (CMC), preferably in a pharmaceutical or biotech setting. Strong experience in US FDA regulations and ICH guidelines. Experience in handling pre- and post-approval submissions is required Interested candidates can share their resumes on sheetal.na@peoplefy.com

Experience : Experience with public health delivery system, research. Job Description : The call is for technical field level support to implement an ICMR project that aims to improve lifestyle in rural communities through self-help groups or volunteers in the village. The project activities involve facilitating the volunteers to mobilize the community for lifestyle modification and follow up persons with non-communicable diseases. The community managers are expected to liaise with the community, the self-help group members and the research team for implementation of the activities. Nature of Job : Term contract appointment for project implementation. Job condition : Community-based project ...

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 pr...

Experience in Regulatory affairs. Exp in CMC and Labeling. Location: Bachupally, Hyderabad.

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you ll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their busines...

All Tech M Location (Hybrid) - 12+ 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 1042867_TechM180087

Role & responsibilities Minimum of 10 years of Life Science industry experience, with substantial exposure to regulatory affairs. Hands on experience and demonstrated expertise in Chemistry, Manufacturing, and labeling processing Comprehensive understanding of global regulatory framework, including FDA, EMA, ICH and other international standards. Excellent communication skills both written and verbal Meticulous attention to detail and organizational prowess Proficiency in project management and cross-functional collaboration Strong analytical and problem-solving skills Ability to navigate and interpret complex regulatory landscapes across multiple regions Good understanding of Quality Manage...

Min 6yrs of experince in Regulatory affairs, CMC. US market exp must location Bachupally, Hyderabad

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinat...

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.