Job 08-012
Regulatory Affairs Associate
Summary & Scope of Position
Coordinate and prepare documents for submissions to regulatory agencies worldwide, as appropriate by project.
Primary Responsibilities:
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Coordinates and/or prepares (i.e., plans, writes, and reviews) materials required for regulatory submissions
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Reviews submission-related documents from pre-clinical, clinical, research, development and manufacturing to ensure consistency with regulatory submissions and compliance with applicable regulations
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Keeps abreast of current US and international regulatory practices, procedures and changes, as appropriate by project
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Assists with regulatory planning and coordination of activities required for US and international submissions
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Monitors and improves regulatory submissions tracking/control systems
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Represents Cerus Regulatory Affairs on project teams (core team and other relevant project teams), as applicable
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Interacts with regulatory authorities on defined matters, as needed
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Participates in the development of regulatory strategies in conjunction with senior RA personnel
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Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
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Perform other related duties as required
Qualifications/Requirements/Skills:
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Bachelor’s degree in a related scientific discipline with a minimum of 2 years regulatory experience
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3 – 4 years relevant experience in a biotechnology, pharmaceutical, or medical device company
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Flexibility; ability to adapt to changing priorities
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Good communication skills (interpersonal, written, verbal, listening)
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Good time management (timelines, schedules, task prioritization)
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Detail and accuracy oriented
How to Apply
Interested Candidates may submit a resume by one of the following methods.
By Mail:Cerus Corporation
Attn: Human Resources
2411 Stanwell Dr.
Concord, CA 94520 |
By Fax:
925-288-6090 |
Online:hr@cerus.com |
For Staffing VendorsCerus does not accept unsolicited resumes from staffing vendors, including recruitment agencies and/or search firms, nor does Cerus pay fees to any such vendors without a current agreement on file. Please do not contact or solicit Cerus hiring managers regarding these matters.
Equal Opportunity Employer
Cerus Corporation is proud to be an equal opportunity employer and extends employment to men and women from culturally diverse backgrounds. We respect and value individual differences and recognize each employee as an integral member of our company. Our work force reflects these values and celebrates the individuals who make up our growing team.
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