עדיין מחפשים עבודה במנועי חיפוש? הגיע הזמן להשתדרג!
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
המימד השלישי
- ראשון לציון
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המימד השלישי
- ראשון לציון
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מלאה
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Clinical RA Director -Hibrid position
Primary purpose and function of this position:
Provide clinical regulatory perspective for development and registration of the company's products, including evaluation of alternative regulatory strategies for clinical development and submission to EU/US and other territories as defined by the company.
Major duties and responsibilities:
Regulatory support for the clinical function
Review strategic documents pivotal for NDA/MAA submission (protocols, reports, etc.)
author and maintain clinical aspects of regulatory documentation (such as IMPD, IB, IND).
Prepare and attend consultation meetings with regulatory agencies as needed.
Top responsibility for clinical parts in regulatory submissions to FDA, EU and other territories regulatory entities.
Track, interpret and advise on US and European regulations
Primary purpose and function of this position:
Provide clinical regulatory perspective for development and registration of the company's products, including evaluation of alternative regulatory strategies for clinical development and submission to EU/US and other territories as defined by the company.
Major duties and responsibilities:
Regulatory support for the clinical function
Review strategic documents pivotal for NDA/MAA submission (protocols, reports, etc.)
author and maintain clinical aspects of regulatory documentation (such as IMPD, IB, IND).
Prepare and attend consultation meetings with regulatory agencies as needed.
Top responsibility for clinical parts in regulatory submissions to FDA, EU and other territories regulatory entities.
Track, interpret and advise on US and European regulations
Requirements:
10 years clinical regulatory experience in pharmaceutical industry (preferably in CNS).
Excellent interpersonal relations
Proven Project management capabilities
Global regulatory experience preferred in NDA/MAA submission
Experience with drug-device combination product/s
Perfect English
Self motivated and proactive
Experience in global pharma
Flexible thinking/ creativity
Life science background
10 years clinical regulatory experience in pharmaceutical industry (preferably in CNS).
Excellent interpersonal relations
Proven Project management capabilities
Global regulatory experience preferred in NDA/MAA submission
Experience with drug-device combination product/s
Perfect English
Self motivated and proactive
Experience in global pharma
Flexible thinking/ creativity
Life science background
This position is open to all candidates.
במקום לעבור לבד על אלפי מודעות, Jobify מנתחת את קורות החיים שלך ומציגה לך רק משרות שבאמת מתאימות לך.
מעל 80,000 משרות • 4,000 חדשות ביום
חינם. בלי פרסומות. בלי אותיות קטנות.
