Regulatory Affairs Manager

Company Description

BYC provides solutions for a variety of startups and growing companies.

One of our clients is a global medical company that develops and manufactures innovative products for hospitals worldwide.

Key Responsibilities:

• Lead the company's registration team.
• Submit applications for product registration.
• Develop registration strategies for new products in the company’s portfolio.
• Provide regulatory consulting and support to the marketing department.
• Manage registration files for existing products.
• Monitor and implement Ministry of Health regulations and standards.
• Manage the quality team, including batch release processes for the company.
• Implement and oversee quality procedures within the organization.

Requirements:

• Licensed Israeli pharmacist with a minimum of two years of experience in drug registration – MUST.
• Experience in regulatory processes with the Ministry of Health – MUST.
• Managerial experience – MUST.
• Experience in PV (Pharmacovigilance), QA (Quality Assurance), and QP (Qualified Person) – Significant advantage.
• High-level or native English proficiency.
• Strong interpersonal skills, assertiveness, ability to develop and enhance areas of responsibility, drive processes, and maintain a strong systemic perspective.