Regulatory Affairs Manager

1 week ago

Petah Tikva Center District, Israel Medomie Full time ₪90,000 - ₪120,000 per year

In this role, you will take ownership of regulatory submissions and approvals in Israel, managing the end-to-end registration process for innovative medicines, generics, and established molecules. You will serve as the key contact with the Ministry of Health and other regulatory bodies, while working closely with internal teams to drive projects forward.

What you'll do:

  • Lead the preparation and submission of regulatory dossiers for new and existing products
  • Manage interactions with the Ministry of Health and other regulatory authorities
  • Oversee the full lifecycle of the registration process: from submission to approval

What we're looking for:

  • Proven experience in pharmaceutical registration in Israel, including complex submissions
  • Strong knowledge of regulatory requirements, procedures, and Ministry of Health approvals
  • Excellent organizational skills with the ability to work independently
  • A proactive, detail-oriented professional with strong communication skills

Please send CVs to:

For questions and inquiries, please contact Itzik Mishali at

דרוש/ה מנהל/ת רישום ורגולציה (לא חובה רוקח/ת ממונה)

לחברת יבוא תרופות במרכז הארץ דרוש/ה מקצוען/ית עם ניסיון מוכח ברישום תרופות בישראל.

התפקיד כולל טיפול מקיף בתיקי רישום חדשים של תרופות אינובטיביות, תרופות גנריות ומולקולות ותיקות, ומעקב צמוד לאורך כל שלבי תהליך הרישום – מא' ועד ת'.

תחומי אחריות:

  • הכנת והגשת תיקי רישום חדשים וקיימים
  • ניהול קשרי עבודה מול משרד הבריאות והרשויות הרגולטוריות
  • אחריות מלאה על מחזור החיים של התיק – מהגשה ועד קבלת אישור

דרישות התפקיד:

  • ניסיון מוכח ברישום תרופות בישראל, כולל טיפול בתיקים מורכבים
  • ידע מעמיק בדרישות רגולציה, נהלים ואישורי משרד הבריאות
  • יכולת עבודה עצמאית וארגון גבוהים

תקשורת בינאישית מצוינת ויכולת עבודה בצוות

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