Regulatory Affairs Specialist

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.

Roles and Responsibilities:

• Responsible for providing advice and support to the project team for regulatory operations aspects of the projects.
• Manage 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.
• Lead project teams and advise 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
• Participate actively in other business related projects (business opportunities, client specific issues, etc.) and planning.
• Client consultation and preparation of quotes and is responsible for achieving utilization goals of the EU unit.
• Completing other appropriate duties as assigned by line manager that require similar skills

Skills Requirement

• Experience in eCTD, NeeS, Paper Submissions.
• Exp in EU, US and Canada HA submissions.
• Exp in Lorenz Docubridge and ISI Tool Box
• Exp in sequence building and document level publishing
• Good knowledge on the CTD sections.

Benefits of Working in ICON

ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart. Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

From a small team of 5 people in 1990, ICON now employs over 13,600 people across 89 offices in 37 countries. We have mainly grown organically, but have bolstered our growth through a number of strategic acquisitions which have broadened our service portfolio and have added scale to existing services. To know more about us visit www.iconplc.com