P222 - Regulatory Submission Manager

P222 - Regulatory Submission Manager

15 oct
|
Infotree Service Inc
|
Buenos Aires

15 oct

Infotree Service Inc

Buenos Aires

Job Description





•    Fully accountable for the success of project start-up;

•    Efficiently manage and successfully execute all aspects of global start-up according to Sponsor specifications, including maintaining start-up timelines;

•    Maintain ongoing Sponsor contact for submission issues by serving as primary contact for Sponsor and project team members;

•    Independently interact with Sponsor, sites, Institutional Review Boards (IRBs)/Ethics Committees (ECs), regulatory agencies, and the our client team;

•    Provide regulatory submissions advice and guidance to our client team to ensure compliance with appropriate regulations and requirements;



•    Quality check of submission documents;

•    Present during bid defenses, general capabilities meetings, and audits;

•    Provide oversight of Regulatory Submissions Coordinators and Clinical Trial Assistants; and

•    Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges. 





Qualifications





•    Bachelor’s degree and 4 years of clinical operations/study start-up experience; or master’s/PhD degree within life sciences and at least 3 years of clinical operations/study start-up experience





Additional Information





Great Benefits.

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https://www.kitempleo.com.ar/empleo/5402084/p222-regulatory-submission-manager-buenos-aires/?utm_source=html

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