RA Associate / Deputy Drug Safety Officer Israel

We are looking for an experienced Regulatory Affairs Associate to lead regulatory activities in Israel and serve as Deputy Drug Safety Officer.

This role is hands-on and operational. You will be responsible for executing the regulatory strategy, submissions to the Israeli Health Authority, and ongoing compliance across the product lifecycle.

Key Responsibilities

• Execute local regulatory strategy in Israel
• Act as a contact with the Israeli Health Authority
• Prepare, submit, and manage regulatory filings, including:
• Initial Marketing Authorization Applications
• Variations and lifecycle submissions
• PSURs
• Regulatory notifications
• Manage Product Information and artwork in line with the registered dossier
• Review and approve promotional materials to ensure regulatory compliance
• Ensure full compliance with company policies, local regulations, and approved dossiers
• Serve as Deputy Drug Safety Officer and support pharmacovigilance activities as required

Required Qualifications

• BPharm with a valid Israeli Pharmacist License
• Minimum 2 years of experience in Regulatory Affairs and/or Pharmacovigilance
• Solid knowledge of the Israeli regulatory landscape and procedures
• Proven experience working directly with regulatory authorities
• Full command of Hebrew
• Excellent English proficiency (written, verbal, presentation)
• Strong communication, planning, and problem-solving skills
• Ability to build and manage effective relationships with internal and external stakeholders

The position is on-site, with a minimal flexibility of 1 day remote working.

Please send your CVs to daphna.avital@astellas.com