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Amgen Clinical Trials Regulatory Submission Manager in Sao Paulo, Brazil

Amgen is now hiring a Clinical Trials Regulatory Submission Manager with Regional or Global experience, based in Brazil.

Job Summary

Our clinical trial activities are growing rapidly and dynamically, and we are currently seeking a full-time, Clinical Trials Regulatory Submissions Manager to join our regional Clinical Trial Regulatory Hub team. This position plays a key role in the clinical trial application management at Amgen, with multi-country scope including and not limited to Latin America, Extended Europe and Middle East countries. If you are looking for an exciting career where you can use your previous expertise and develop your career to a diverse multi-country scope, then this is the opportunity for you.

The Clinical Trials Regulatory Submission Manager is responsible for the overall submission strategy definition, execution and management of all regulatory activities for clinical trial projects and programs, according to local regulatory regulations and Amgen’s policy. In Brazil, this position is directly accountable for clinical trial application preparation and submission to ANVISA. In other countries, is accountable for the oversight of activities executed by outsourced functional service providers (FSP), according to Amgen FSP hub model.

This position works directly with Functional Service Providers for Regulatory and Ethics Committee Services, Clinical Project Management, Global Study Operations, International Regulatory Team and CMC Global Product Leads.

Responsibilities Summary

  • Efficiently end-to-end manages regional Clinical Trials Regulatory submission hub for new and ongoing project(s) or programs, including and not limited to clinical protocol amendments, quality (CMC) amendments, import licenses obtention, study periodic reporting, until the project is officially closed.

  • Develops, with the input of functional service providers, study specific submissions and approvals plan and keeps it updated.

  • Monitors team efficiency, quality and adherence to project timelines, SOPs and local regulations.

  • Communicates overall regulatory status to internal teams and service providers.

  • Attends to project meetings with cross functional department leads to provide strategy, timelines and requirements for regulatory submissions and approvals.

  • Works with internal team members to establish and clarify regulatory requirements

  • Maintains clinical trial regulatory requirements database, including regular updates to checklists.

  • Coordinate with local and global team CTA pre-submission meetings with Agency, if needed.

  • Where applicable, provides work instructions to team members in preparation of regulatory submissions, timeline estimations, issues resolution, etc.

  • Facilitates communication with the regional or local study team (e.g. SSU CRA, SSU Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.

  • Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.

  • Develops proactive solutions to regulatory start-up issues and challenges; and

  • Represents regional hub in general local, global meetings, inspections and audits.

Minimum Qualifications

  • BS/BA/BSc or equivalent in a health-related field plus 6-7 years of related clinical trials experience

  • within the total years of experience, at least 3-4 years of regulatory submissions / study start-up experience is required

  • Strong technical knowledge and experience in executing Clinical Trial Applications in Brazil (ANVISA)

Knowledge and Soft Skills

  • Experience and/or technical knowledge in other countries will be plus;

  • Excellent written and verbal communication skills in English;

  • Desirable written and verbal communication skills in Spanish

  • Ability to conceptualize, develop and manage timelines, including its updates;

  • Ability to delegate and make decisions, including risk-based ones;

  • Ability to manage multiple projects and priorities;

  • Ability to develop and maintain productive relationships with coworkers, managers and service providers.

Ability to work independently and asynchronously with different time zones within a matrixial project team environment is essential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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