Manager, Regulatory Publishing

Manager Regulatory Publishing

JR118180

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 fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: 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. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Overview:Responsible for oversight of compilation of regulatory submissions (NDA, MAA, IND) in eCTD format for assigned projects/countries/sites.The role:

• Responsible for providing 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 the 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 client consulting with other resources within 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 and achieve utilization goals of the EU unit.• Completing other appropriate duties as assigned by line manager that require similar skills• Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.• Travel (25%)• Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.You will need:

• Bachelor Degree• 5 to 8 years of exp.• 2 to 4 years of Publishing exp.• Regulatory Exp.• Advanced English to Write, read and speak

Homeworker positionBenefits 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 very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.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.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

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