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Regulatory Affairs Senior Manager (12 month contract) Mississauga Canada,  

Posted on : 01 May 2017

Project Description

Responsibilities:Contribute to and successfully execute strategies and tactics for Amgen Canada s federal Regulatory Affairs work in one or more therapeutic areas, with full responsibility for clinical aspects and oversight of CMC aspects, including preparation and management of submissionsManage and deliver on overall project objectives and performance targets while maintaining quality and ongoing compliance with all applicable regulationsLead dialogue and negotiations with Health Canada to successfully resolve issuesWork cross-functionally as an integral part of the R&D and Commercialization teams of Amgen CanadaContribute to global regulatory planning via liaison with international Amgen counterpartsMentor junior staffSome travel involved#LI-POSTBasic QualificationsB.Sc. degreePreferred QualificationsB.Sc. degree in natural sciences (e.g., biology, biochemistry, pharmacology, toxicology)10 years of work experience in Regulatory AffairsThorough understanding of Canadian regulations, guidances, policies and other relevant practices in pharmaceutical and biological drug developmentExcellent communication and presentation skills, both oral and writtenPositive leadership qualitiesStrong decision-making and problem-solving skillsAbility to manage and advance multiple activities concurrentlyProven ability and commitment to work within Amgen s cross-functional operating styleAmgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact to make a request and ensure you include the requisition number.Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview


Canada, Mississauga

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