3208 Regulatory Affairs Jobs - Page 31

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...

Role & responsibilities Develop good relation with policy makers in Central Government, Regulatory Authority, officers of various state governments energy department, Private Sector Power Producers, State Electricity Board and Intermediaries SECI & NTPC and DISCOMs. Understand the implication of existing Government Policies, Rules & regulations formulated by different Central and State Regulators Keeping abreast with changes in Regulatory regime at Central and State level. Expediting Tariff Adoption, Trading Margin & Procurement approval from CERC & SERCs. Analysis of PPAs/PSAs, Bidding documents etc from Regulatory impact perspective. Interfacing at APTEL, CERC, SECI and NTPC. Provide regul...

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...

In this vital role, you will be responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Working in close collaboration with cross-functional teamssuch as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chainyou will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards. Key Responsibilities Global Labeling Coordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuri...

Roles & Responsibilities: Lead the preparation of clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with applicable regulations, guidance, and company requirements Work closely with the transparency and disclosure team and with cross functional stakeholders to define redaction strategy, to ensure timely and accurate registration and results review/approval process, including the redaction process, for US and EU registries, lead cross functional review and approval, ensure submission readiness, and hand off for timely submission or posting Support trend analysis and continuous improveme...

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...

About Zscaler Serving thousands of enterprise customers around the world including 45% of Fortune 500 companies, Zscaler (NASDAQ: ZS) was founded in 2007 with a mission to make the cloud a safe place to do business and a more enjoyable experience for enterprise users. As the operator of the world’s largest security cloud, Zscaler accelerates digital transformation so enterprises can be more agile, efficient, resilient, and secure. The pioneering, AI-powered Zscaler Zero Trust Exchange™ platform, which is found in our SASE and SSE offerings, protects thousands of enterprise customers from cyberattacks and data loss by securely connecting users, devices, and applications in any location. Named...

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

Roles and Responsibilities Review documents from various departments to compile regulatory submission. Oversee drug master file for submission to regulatory authorities, including updates, amendments, and revisions as required. Draft both the applicant and restricted parts of DMF s to ensure regulatory complience. Coordinate with CFT to address deficiency and feedback from RA and customers. Conduct CFT meetings to ensure timely responses to regulatory deficencies and customer inquires. Provide regulatory guidance to product development teams and attend technology transfer meetings to support compliance. Respond promptly to technical queries from regulatory bodies and customers.

The Director leads the strategic development and execution of the Global Regulatory Intelligence (GRI) function, ensuring Amgen stays ahead of an evolving global regulatory landscape. This role defines the team's mission, sets priorities, leads cross-functional collaborations, and ensures high-impact intelligence is embedded into regulatory strategy across the enterprise. Key Responsibilities: Function Leadership & Vision: Establish and evolve the Regulatory Intelligence function, defining structure, staffing strategy, vendor/outsourcing model, and the technology roadmap to support global operations. Set the vision and oversee the execution of intelligence deliverables that enable accelerate...

Roles and Responsibilities: Conduct quality assurance reviews and process the daily release of FDA Form 2253 reportable submissions for promotional materials referencing marketed products. Evaluate creative file submissions and system metadata of marketing materials, ensuring completeness, accuracy, and compliance with licensing requirements. Collaborate with creative agencies and marketing teams to oversee the renegotiation, renewal and collection of usage rights for marketing materials. Leverage company subscriptions to provide art procurement services in support of Amgens marketing initiatives. Retrieve, validate, and distribute digital asset packages to agencies and marketing teams, util...

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...

What you will do Lets do this. Lets change the world. Roles & Responsibilities: Act as the Regional Service Delivery Lead for Deskside Support Services, representing DSS across regional IS and business teams. Lead and manage the MSP to ensure effective delivery, performance, and continuous improvement of deskside services. Partner with global DSS service owners and regional IS leads to align regional service models with global strategy. Monitor and govern SLAs, KPIs, and operational metrics, ensuring service excellence and proactive remediation of issues. Supervise hardware asset management and device lifecycle processes, including procurement, deployment, and retirement. Leverage platforms ...

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...