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Senior Manager Regulatory Affairs
ICON is currently recruiting for a Senior Manager, Regulatory Affairs to join our Strategic Regulatory & Safety Consultancy 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. We’re headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff. The Senior Manager, Regulatory Affairs has responsibility to provide comprehensive regulatory services for clients requiring support for registration and maintenance activities in for pharmaceuticals, biologics, and other product types. This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients. The work will entail primarily working with Health Canada submissions and assessments. This role is responsible for ensuring project/ program timelines and budgets are met and maintaining client relationships in support of future business. The role is responsible for support of activities to secure new clients/business. This position may or may not have direct reports. The primarily responsibilities of this job include: Effectively-prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance. Assess and update clinical and non-clinical sections of the dossier to meet Canadian requirements.More information on this Job
ID: 14694124 - Save Job
: Recruitment Jobs
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