299 Cmc Jobs - Page 2

2. Should be able to handle the breakdowns with the team and individually. 3. Awareness of Hydraulics, Lubrication, and Other Oils (like Engine, Transmission, etc.). 4. Awareness of fasteners, weld joints, and pipeline routing. 5. Awareness of electrical-related works. 6. Awareness of EMS, QMS, and OSHAS Documentation. 7. Awareness on 5S Implementation and Guidance to Supervisor and below. 8. Able to complete the preventive maintenance according to the schedule. 9. Awareness of the Pneumatic and Hydraulics Symbols. 10. Liaison with other departments. 11. Awareness of safety precautions while working on mechanical works. 12. Should follow up on the logbook records, like oil consumption, daily...

Role Overview: As an Assistant Manager Service at GD NASH, a part of Ingersoll Rand engineered solutions division & part of PFT, you will play a crucial role in handling Warranty and out of warranty Service issues in Centrifugal blowers and Liquid Ring Pumps. Your responsibilities will include contacting old and new customers for Service Revenue Initiatives by offering AMC/CMC/Rental, finalizing quotes with customers, resolving customer complaints in a timely manner, organizing installation activities efficiently, coordinating between engineering and quality for product issues, developing Dealer Service capabilities, arranging training at customer end, and leading service manpower. Key Respo...

Primary Responsibilities: Manage the preparation and submission of new product registrations, post approval submission and follow-up closely on queries and through approval. Responsible for writing CMC modules 2 & 3. Exposure to EU & CIS region in Regulatory filings Manage and coordinate product life cycle management. Ensure regulatory compliance with local regulatory requirements. Foster and maintain professional relationships with the health authorities. Provide regulatory support including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary. Maintain regulatory work processes and tracking tools that improve per...

Role & responsibilities CMC and Labelling: Preparation of ANDAs in eCTD format for various type of formulations Review of the technical documents such as Specifications, BMR, MFC, Able to work on All type of CTD section write-ups Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS) Through knowledge on ICH guidances Should able to handle Module -I related activities Able to review Drug substance DMF and should prepare a due diligence eCTD Related activities: Complete knowledge on eCTD related publishing activities Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC’s etc., should adhere to FDA published latest gui...

Description Allianz POC 3 CMC - MD Expert Business Partner-C2#31 Deliverables Map existing local Business Partners to harmonized Business Partners - Identify gaps - Request from the OE missing BPs - Delete obsolete BPs - Perform Regression test Named Job Posting? (if Yes - needs to be approved by SCSC) Additional Details Global Grade D Level To Be Defined Named Job Posting? (if Yes - needs to be approved by SCSC) No Remote work possibility No Global Role Family 60236 (P) Software Engineering Local Role Name 6361 Software Engineer Local Skills 37116 SAP Finance Languages RequiredEnglish Role Rarity To Be Defined

About The Role Skill required: Provider Network - Life Sciences Regulatory Operations Designation: Health Operations Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, bud...

Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745). Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers. Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle. Assess the regulatory impact of product and process changes and ensure proper documentation and notification. Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings. Review and approve produ...

Description Regulatory Manager (CMC, EU Japan/China) 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...

HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline, About The Role Key Responsibilities Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate ind...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

We are looking for a Senior STEM Content Analyst with strong expertise in CMC Biologics to join our Life Sciences team in India. The ideal candidate will have a solid background in pharmaceutical development or regulatory affairs, particularly in biologics and biopharmaceuticals, and will be passionate about delivering high-quality content that supports global health authority submissions. You will be responsible for monitoring regulatory changes, authoring detailed CMC reports, and supporting both internal teams and external customers. Your ability to work collaboratively across global teams, manage complex regulatory data, and contribute to product innovation will be key to your success in...

Responsibilities: Assist in the preparation and compilation of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets. Support the collection and review of technical documents from R&D, QA, QC, and Production departments. Help maintain regulatory databases, tracking sheets , and product registration status logs. Learn and follow current regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO) . Assist in the submission of post-approval changes , annual updates, and renewal applications. Draft and format regulatory documents, letters, and summaries . Help respond to regulatory agency queries and deficiencies under guidance. Ensure compliance with documentation practice...

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

What you will do 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 Management, Monitoring, and Engagement...

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. The Regulatory Compliance team is a part of RA CMC and is seeking to expand its capacity in India . The Regulatory Compliance team performs assessment of operational changes for regulatory reportability and maintains state and federal licenses for Amgen products across phases of development, modality, and countries. The team member will be responsible for maintaining U.S. state and federal com...

The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes p...

The Senior Associate in Regulatory Affairs at Amgen plays an important role in ensuring that the company's products meet and maintain regulatory standards. They assist in preparing submissions for regulatory agencies, keep updated on changes in regulatory legislation, and guide various teams within the company to ensure compliance with applicable regulations. R egulatory 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. The Regulatory Compliance team is...

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 ...

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. Key Activities Contributes to product teams and act...

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

Role description: Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgens GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintai...

Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates a...

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. Amgens CMC submission execution team, R egulatory O ptimization o f T actical and S trategic S upport (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC t...

Role & responsibilities Location: Bidar, KA Role: Sr QA Lead JOB DESCRIPTION: 1) Handling of Quality management system. 2) Monitoring Process validation program. 3) Handling of customer and regulatory audits. 4) Monitoring Equipment Qualification program. 5) Coordinate with cross functional team to provide audit response to customer and regulatory agencies. 6) Conducting internal audits as per schedule. 7) CAPA effectiveness verification. 8) Conducting Quality review board meetings and management review meetings as per schedule. 9) Monitoring Equipment cleaning program. 10) Providing necessary documents to address Regulatory Queries, amendments, annual updates and regulatory filings and CMC ...

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries . • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation . • Ensure submission t...