581 Ctd Jobs - Page 5

1. Regulatory Affairs: - o Prepare, compile, and submit regulatory dossiers (e.g., CIBRC, CDSCO, EU, etc.) for registration of agrochemical, disinfectants, biocide and food contact material products. o Liaise with client and regulatory authorities for approvals, clarifications, and queries. o Maintain up-to-date knowledge of regulatory requirements in India and international markets. o Support risk assessment and labeling compliance for products. 2. Toxicology & Safety Evaluation: o Review and interpret toxicology, Endocrine disruptors and ecotoxicology study reports. o Coordinate with external labs/CROs for conducting toxicological and ecotoxicology studies. o Maintain regulatory and toxico...

Were Hiring for Regulatory writers Location: Bang, Hyderabad, Mumbai, Pune, Delhi NCR. Hybrid mode of work ( 2 days WFO ) Experience : 4 yrs to 12 years Role & responsibilities Seeking experienced regulatory writers to author key clinical documents (e.g., CSRs, protocols, IBs, CTD summaries) in compliance with global regulatory requirements. Must demonstrate strong scientific knowledge, lean writing practices, and the ability to lead cross-functional teams through document planning, development, and finalization. Proficiency in MS Word, document management systems, and structured content tools is essential. Ability to manage timelines, ensure consistency, and work independently or across the...

We are looking for a skilled Income Auditor to join our team, with 3-6 years of experience in the hospitality industry. The ideal candidate will have a strong background in auditing and financial analysis. Roles and Responsibility Conduct audits to ensure compliance with financial regulations and standards. Analyze financial data to identify trends and areas for improvement. Develop and implement audit plans and procedures. Collaborate with cross-functional teams to resolve audit findings. Prepare and present audit reports to management. Identify and mitigate risks associated with financial transactions. Job Requirements Strong knowledge of accounting principles and financial regulations. Ex...

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...

Sr Manager - Gen Med Biosims International Regulatory Lead The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements. Group Purpose International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules. Job Summary The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high impact to Amgen. Provide Guidance and Leadership on mechan...

ABOUT THE ROLE The Regulatory Affairs Senior Associate role assists US Promotion Regulatory representatives and other cross-functional roles in the administration of regulatory strategies for department initiatives across all product brands. This role assists with preparing, tracking, reporting, and archiving US regulatory documentation, including preclearance and advisory comment promotional materials, and is responsible for all Ad/Promo regulated data management. This role performs the planning and tracking of all US promotional label changes and manages the system update of promotional labeling and Important Safety Information (ISI). This role is responsible for US digital labeling and tr...

ABOUT AMGEN Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, or prepare documents for public registries e.g. ClinicalTrials.gov Work closely with cross functional stakeholders to define redaction strategy and disclosure, lead review and approval, ensure submission readiness, and hand off for timely submission or posting Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Communicate with team members or cross-functional stakeholders to resolve problems and escalate issues Record and maintain w...

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...

Before you apply to a job, select your language preference from the options available at the top right of this page. Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrowpeople with a unique combination of skill + passion. If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level. About The Role : Job Summary This position provides input, support, and performs full systems life cycle management activities (e.g., an...

At Sogeti, we believe the best is inside every one of us. Whether you are early in your career or at the top of your game, well encourage you to fulfill your potentialto be better. Through our shared passion for technology, our entrepreneurial culture , and our focus on continuous learning, well provide everything you need to doyour best work and become the best you can be. Your Role Looking for the candidate having 3-5 yrs of experience. Location- Mumbai Key Responsibilities: Lead Azure cloud migration for large-scale workloads and modernization projects. Validate Azure environments and ensure seamless workload transitions. Recommend Azure technologies aligned with governance, compliance, a...

Position Regulatory Consultant Company Information Our client is a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. They have their head office in Mumbai and subsidiaries in Singapore, Malaysia, Australia and in Europe. The company has been providing high quality & timely consulting service to the Pharmaceutical Industry in India and internationally. The company has a young and committed team of GMP and Regulatory Experts. The company is inviting applications for the role of Regulatory Consultant and are looking for dynamic, driven individuals with strong initiative who can thrive in the entrepreneurial environment at our firm. Role & Responsib...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

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

The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgens local regulatory teams, for the Managers assigned areas of responsibility. Thi...

Role Description: We are seeking a detail-oriented and globally minded Manager, Total Rewards to oversee the administration and execution of total reward programs, including employee benefits and equity plans for the Americas region. This role plays a key part in ensuring operational excellence, and an exceptional employee experience related to total rewards programs. The ideal candidate will have strong working knowledge of U.S. and LATAM total reward programs, experience leading teams, and a passion for delivering seamless reward operations. Roles & Responsibilities: Regional Program Administration (Americas) Manage the day-to-day administration of benefits programs (health, welfare, retir...

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...

Role Name: Manager International Regulatory Lead (IRL) Department Name: International Regulatory Team, Global Regulatory Affairs Role GCF: 5A ABOUT THE ROLE Role Description The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to -optimize product development and regulatory approvals in International countries -develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities -Advises Global teams on regulatory impl...

Roles & Responsibilities: Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and the agreed strategy defined by the cross functional team Ensure consistent quality across documents, ensure submission readiness, and hand off for timely submission or posting Collaborate with team members to resolve problems and escalate issues Record and maintain written redaction strategy for the study and product Manage timelines and coordinate work across team Execute clinical trial disclosure business process and ensure deliverables and delivery timelines in compli...

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...

What you will do In this vital role you will Prepare and oversee the preparation of regulatory submission documents that comply with global regulatory standards Write or oversee the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phase 1 through 4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety documents, across therapeutic areas and for biosimilars (mandate) Write other regulatory submission documents (eg, RTQs, PIP, white papers, breakthrough therapy...

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...