Regulatory Affairs Senior Manager (12 month contract) - Mississauga, CANADA - ONTARIO | Biospace
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Regulatory Affairs Senior Manager (12 month contract)

Amgen

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Location:
Mississauga, CANADA - ONTARIO
Posted Date:
5/28/2017
Position Type:
Full time
Job Code:
R-35386
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job 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 submissions

Manage and deliver on overall project objectives and performance targets while maintaining quality and ongoing compliance with all applicable regulations

Lead dialogue and negotiations with Health Canada to successfully resolve issues

Work cross-functionally as an integral part of the R&D and Commercialization teams of Amgen Canada

Contribute to global regulatory planning via liaison with international Amgen counterparts

Mentor junior staff

Some travel involved

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Requirements

Basic Qualifications

B.Sc. degree

Preferred Qualifications

B.Sc. degree in natural sciences (e.g., biology, biochemistry, pharmacology, toxicology)

10 years of work experience in Regulatory Affairs

Thorough understanding of Canadian regulations, guidances, policies and other relevant practices in pharmaceutical and biological drug development

Excellent communication and presentation skills, both oral and written

Positive leadership qualities

Strong decision-making and problem-solving skills

Ability to manage and advance multiple activities concurrently

Proven ability and commitment to work within Amgen's cross-functional operating style

Amgen 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