Global Regulatory Affairs Lead

ICON is offering an opportunity to work within our dedicated, talented, supportive and friendly Global Regulatory Clinical Services (GRCS) team in clinical trials. The GRCS team has been in operation for 25+ years and comprises more than 400 regulatory professionals located in 48 countries, managing submissions in 60+ countries.

As part of the GRCS team, the Global Regulatory Affairs Associate (GRAA) fulfills the role of Global Regulatory Affairs Lead (GRAL) and is responsible for managing and coordinating Regulatory Agency (RA), Central Ethics Committee (CEC), and other central authority submissions for global clinical trials.

This includes communicating the status of submissions to the Start-Up Lead(s) (SULs) and working with them to mitigate risks to Sponsor deliverables. In addition, the GRAL is responsible for providing the Sponsor and internal Project Team information on regulations governing the clinical trial at a project level and answering any Sponsor questions surrounding these topics.

Individual Responsibilities:

- Management, submission strategy and coordination of Regulatory Agency (RA), Central Ethics Committee (CEC) and other central or country level authority submissions.
- Be the main point of contact for the regulatory submissions and provide the client and the internal team with information on regulations and drug considerations at a project level.
- Provide submission strategy to the client along with all requirements and documentation requests to actualize proposed strategy.
- Preparation and review of the core documents and QC on the content of the submission packages to ensure they meet the needs of the trial protocol, sound scientific and therapeutic area principles and any other study requirements.
- Depending on the scope of the project, create the master IP labels or ensure that Sponsor provided IP labels are in adherence with Annex 13 or applicable regional requirements. Coordination and management of country level labeling translation.
- Depending on the scope of the project, develop and/or review global informed consent form(s) (ICFs). Coordination and management of country-level ICFs.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable ICON systems.
- Perform role of Global Reviewer in the QC process as appropriate.
- Take on responsibility for Subject Matter Expert as designated by Global Regulatory Clinical Services Management.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
- Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Intelligence Database and the Country Fact Sheets are up to date; communicate any new information or changes received to the Regulatory Intelligence Consultant team.
- Provide regulatory consulting services
- Provide mentoring and training, as needed.
- Support colleagues with more complex submissions requirements, as needed.
- Support the development of new processes and participate in departmental initiatives.

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.