Regulatory Affairs Specialist
About the role
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ICON is currently recruiting for a Regulatory Affairs Specialist to join our Strategic Regulatory Services (SRS) group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe-from biotech startups to big pharma-as well as the research firms that serve them.
The Regulatory Affairs Specialist has responsibility for providing comprehensive regulatory services to clients within the pharmaceutical, biologic, medical device or other regulatory service environment. This will include support for assessment, registration, maintenance and other activities as assigned. The primarily responsibilities of this job include:
Supports Manager/Directors/project teams in the preparation of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance.
Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.
Attends formal interactions (face-to-face meetings, teleconferences etc) with clients, and possibly, government agencies. Builds positive working relationships with clients.
Assists in the development of assessments and strategic regulatory plans for client product development programs
Supports the development of initial or alternative strategies, consulting with their manager or other resources within the organization. Assist in identification of project issues.
Responsible for supporting project workflow, including prioritizing project objectives for smaller projects and portions of larger projects, and establishing timeframes for projects with guidance from Manager/Director/senior team members.
Responsible for overseeing progress and completion of their own projects and sub-projects ensuring timeframes and deadlines are met
Supports submission approvals through effective communication with project team and client.
Reviews applicable client source documents to ensure they are consistent and editorially correct
Required experience:
Minimum of BS in Life Science, healthcare, engineering preferred
Post-graduate certificate in regulatory affairs preferred
Minimum of 2 years of relevant experience
Health Canada submission experience preferred
Understanding of local Health Authority regulations, guidelines, policies
Ability to maintain a high level of accuracy and attention to detail
Effective project management skills
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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