5151 Regulatory Jobs - Page 37

Key skills required by this role includes: Understand Regulatory operations Gather, review and analyse data regarding the business and its operations; prepare models and process maps for improvements; and communicate findings and suggestions to key stakeholders Understanding software requirements, ability to translate business need into functional and technical requirements Skilled in documentation and timely response and sharing of information Ability to perform discussion with customer Ability to effectively report on status of work Break down requirements in user stories Ability to verify the functionality in the solution. Ability to write test cases/scripts and execute them.

Position Summary: Freyr is seeking an experienced individual to join their Medical Device Team. This position involves working directly with clients with software enabled medical devices or software as a medical device to serve as an advisor on regulatory strategy including the development of regulatory strategy documents, documentation to support premarket submissions, and preparation and submission of premarket applications as well as participation in FDA meetings and other regulatory interactions. The role is 50% billable with the remaining time being devoted to business development/marketing as well as mentorship and training of the more junior staff. The ideal candidate will possess in-...

Skill required: Sales Operations - Sales Enablement Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Transforming sales to become a future-ready and digital B2B revenue engine...

Skill required: Network Operations - Retirement Planning Services Designation: Quality Engineering Associate Qualifications: Any Graduation Years of Experience: 1 - 3 Years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do We help insurers redefine their customer experience whil...

Skill required: Sales Operations - Sales Enablement Designation: Quality Auditing Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Transforming sales to become a future-ready and digital B2B revenue engine...

About The Role Design and implement digital customer journeys using Temenos Journey Manager. Collaborate with business analysts, UX designers, and backend developers to translate requirements into effective solutions. Develop and configure TJM components including forms, workflows, APIs, and UI logic. Ensure optimal performance, scalability, and security of TJM-based applications. Integrate TJM with core banking systems, CRM platforms, and third-party APIs. Conduct testing, debugging, and deployment of digital journeys. Provide technical documentation and support for TJM configurations and customizations. Stay updated with TJM product updates and industry best practices. Primary Skills Requi...

Qualification: MBA /Engineer Experience: Procurement experience of around 4-6 years in FMCG or related industry; manufacturing, contract and financial management skills mandatory Knowledge & skills: Strong commercial acumen & negotiating skills Excellent data management skills Ability to build good relationship & influencing skills with people Good understanding of should-costs and relevant information on drivers for the category Long term value creation Best suited for someone who Likes to work with data and is extremely analytical Has a strong commercial focus Brings an external focus to work, by being constantly updated on developments and innovations in the external world Is able to buil...

The Principal Data Standards Analyst (Laboratory Expert) plays a crucial role in ensuring the accurate standardization, integration, and management of laboratory data across clinical studies. This role supports Clinical Information Governance (CIG), Trial Operations (TO) , Data integration, Translational Medicine, Sample Management, and external vendors, ensuring compliance with CDISC standards (SDTM, CDASH, Controlled Terminology) and regulatory requirements. The Principal Data Standards Analyst (Laboratory Expert) also provides specialized oversight on laboratory data handling, collaborating with internal teams and external central laboratories to mitigate risks related to biomarker, genom...

What you will do In this vital role you will conduct complex complaint investigations, resolves corrective actions with their effectiveness and resolves steps necessary to ensure the proper level of control for product in distribution. We are seeking a Specialist Quality Complaints Complaint Owner and member of the Product Complaints and Surveillance team. The Product Complaints and Surveillance team owns and implements the end-to-end global complaint process and management system, ensuring appropriate business connection across Amgen. In doing so, the focus is on assuring complaint processes and systems remain fully compliant through the quality operating standards and procedures to current...

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...

Live What You Will Do The External Workforce Sr. Manager is responsible for supporting the management and coordination of the organization's external workforce in partnership with our Master Service Providers (MSP), including contingent workers, independent contractors, vendors, and service providers. This role will lead the planning, governance, and operational management of our external workforce to ensure the efficient use of labor categories and other external resources across the organization while maintaining compliance, optimizing cost, and enhancing workforce agility. This role works cross-functionally with HR, Procurement, Legal, IT, and department heads to ensure cost-effective and...

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...

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...

HOW MIGHT YOU DEFY IMAGINATION Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a cr...

Summary: Shall be responsible for ensuring the day-to-day operations and maintenance of the organization's security Posture. Strengthen security posture and ensure the control effectiveness of security systems within an organization. Collaborate with diverse teams to ensure the seamless functioning of the Solutions, optimization of the security infrastructure and controls. Knowledge: 1.Should have sound understanding & knowledge of Sec DevOps, OWASP Web and Mobile Vulnerabilities. 2. Should have hands on experience on WAF, IPS, SSL Offloader, API Security, incident response techniques and technologies. 3.Should have knowledge & understanding of Cloud Technologies, IT infrastructure & network...

Summary: Sr. SOC technologies and Management, shall be responsible for ensuring the day-to-day operations and maintenance of the organization's security. Strengthen security posture and ensure the control effectiveness of security systems within an organization.Collaborate with diverse teams to ensure the seamless functioning of the Solutions, optimization of the security infrastructure and controls. 1..Sound experience in managing SOC technologies and operations in a large and complex environment. 2.Should have sound understanding & knowledge of various SOC technologies & techniques like SIEM, SOAR, UEBA, NBAD, Threat Intel, Deception etc. 3. Should have hands on experience on SOC platform ...

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 ...

What you will do Amgen manufactures and markets biopharmaceutical products that are subject to oversight and regulation globally. It is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious diseases. Amgens new Hyderabad site will play a key role in the next phase of company innovation by designing and embedding new technology solutions and digital capabilities in all functions across the enterprise, leveraging artificial intelligence (AI), machine learning, and emerging technologies. These technologies, strategically applied by Amgens rapidly-scaling local workforce, will also help Amgen efficiently su...

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...

Role Description: The Senior Manager Quality Compliance External Affairs will enhance quality, compliance, and regulatory flexibility by providing leadership and support of external activities impacting Amgens Operations function with link to Regulatory Affairs-CMC, with a regional focus on Japan & Asia Pacific (JAPAC). This role will shape, coordinate and provide input in the development of policy, regulatory requirements, and expectations consistent with Amgens position and priorities on GMP/GDP primarily in JAPAC and regarding related international organizations (e.g., APEC, ICH, Pharmacopoeias, PIC/S, WHO) in support for GCP, GLP, GPvP compliance, as requested. The senior manager will ex...

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...