Manager Regulatory Publishing | ICON plc | Brazil
Site: SP Brazil / Mexico and Guatemala
At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfill our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touchpoint.
Overview: Responsible for oversight of compilation of regulatory submissions (NDA, MAA, IND) in eCTD format for assigned projects/countries/sites.
The role:
Provide advice and support to the project team for regulatory operations aspects of the projects.
Lead and ensure maintenance of a positive and productive liaison with internal and external contacts (i.e. regulatory agencies, clients, co-workers, staff, etc.).
Maintain a strong customer service management approach with clients.
Liaise with country-specific regulatory affairs personnel for technical aspects of international submissions and registrations.
Represent the company in the industry/agency electronic standards working groups.
Lead project teams and advise other departments on regulatory standards issues and strategies.
Develop, write, and implement standards and procedures related to regulatory operations.
Identify client issues and develop alternative strategies for presentation to clients, consulting with other resources within the organization as required.
Present services to clients/potential clients to develop new business.
Present training and seminars.
Participate actively in other business-related projects (business opportunities, client-specific issues, etc.) and strategic planning.
Client consultation and preparation of quotes to achieve utilization goals of the EU unit.
Complete other appropriate duties as assigned by line manager that require similar skills.
Provide regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.
Travel (25%).
Investigate proactively and capitalize on regulatory information collected throughout studies and maintain Regulatory database accordingly.
You will need:
Bachelor Degree
5 to 8 years of experience
2 to 4 years of Publishing experience
Regulatory experience
Advanced English to write, read, and speak
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent. We offer competitive salary packages and a range of health-related benefits to employees and their families.
ICON 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.
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