Description
Every day, Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. KSR is the first and largest scientific staffing company in the world, and we currently have an exciting direct hire full-time Senior Regulatory Affairs Associate position available in the Fort Collins, Colorado area.
Purpose and Scope
Under minimal supervision, perform all functions pertaining to domestic and international regulatory submissions including review of documentation, preparation of documents for electronic or paper filing, compilation of submissions, and review/approval of final submissions.
Essential Duties & Responsibilities
Serve as regulatory representative on project teams. Offer regulatory opinions with consultation from senior regulatory management.
Coordinate with personnel from other departments to obtain data/documentation for submissions and maintain timelines.
With supervision from Regulatory Manager, act as liaison with regulatory agencies.
Review draft investigational and commercial labeling artwork.
Assist Regulatory Manager as requested.
Perform regulatory research tasks as requested.
Assist in or maintain product applications (INDs, NDAs, ANDAs).
Maintain electronic document management system as required.
Conform to regulatory department standards.
Prepare and assist in preparation of domestic and international regulatory submissions.
Provide training and guidance to other staff members when needed.
Provide review of informed consents and protocols.
Maintain up-to-date knowledge of current guidance and regulations.
Perform various other duties as assigned.
Requirements
Education & Experience
Bachelors degree in related field.
Four or more years experience in the pharmaceutical/biologic industry with knowledge of preparing and submitting regulatory dossiers/applications to regulatory agencies.
Benefits & Compensation
Generous salary dependent on experience plus benefits
Competitive health care package
GREAT vacation and paid time off
Relocation assistance provided
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