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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.
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ID: 14694124 - Save Job
Category: Jobs : Recruitment Jobs
Employer Info:
Senior Manager Regulatory Affairs IconPlc


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