Regulatory Affairs Specialist

 We are seeking a Temporary Regulatory Affairs Specialist to join our team and play a key role in managing regulatory compliance for commercial products.

Key Responsibilities:

    •         Prepare and submit regulatory filings, including supplements and annual reports, to the FDA.

    •         Review and compile documents such as monographs, stability protocols, manufacturing instructions, and other regulatory materials.

    •         Approve document changes and determine the appropriate reporting categories for regulatory authorities.

    •         Manage submission tasks and respond to FDA deficiency letters with attention to detail and accuracy.

Position Details:

• Location: Padagis Yeruham
• Full-time position, Sunday- Thursday. Overtime may be required

What You’ll Need:

    •         Bachelor’s degree in Chemistry/ Chemical Engineering/ Biotechnology Engineering/ Life Science – mandatory.

    •         Strong English proficiency, especially in reading and writing – mandatory.

    •         Prior experience in regulatory affairs within the pharmaceutical industry – an advantage.

    •         Ability to manage multiple tasks and collaborate across teams.

    •         Excellent analytical skills and attention to detail in document review.

    •         A proactive mindset with strong problem-solving abilities.

If you’re ready to take on this exciting opportunity we’d love to hear from you!