Global Vaccine RA Director

אודות חברת פיברו בריאות בעלי חיים חברת פיברו בריאות בעלי חיים הינה חברה בינלאומית בבעלות ציבורית בעלת פעילות ענפה של למעלה ממאה שנים בייצור בגלובלי של תוספי מזון רפואיים, תרכיבים ותרופות ומספקת פתרונות ייחודיים מתקדמים לענף החי ברחבי העולם. הפעילות של פיברו נאמדת בכמעל 820 מיליון דולר. פיברו מעסיקה למעלה מ-1500 עובדים ברחבי העולם.Phibro seeking a Global Vaccine RA Director.To lead RA global team to support business goals according to global strategy while maintaining compliance with local regulations around the globe. Responsible for RA intelligence and pharmacovigilance.Reporting to VP Operation.Phibro Animal Health Corporation is a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of feed additives, feed ingredients, advanced nutrition solutions, vaccines, and specialty chemicals for various industrial markets. Phibro’s revenues are more than $820 million and are supported by over 1500 employees worldwide.Key Responsibilities:

• Lead Phibro’s Regulatory Network with global RA teams based in the markets working on biologicals.
• Global registration strategy and operations
• Execute global regulatory work plans and projects to support and drive product registrations.
• Maintain registrations materials and approvals, including LCM library updated and accessible to QA/RA teams
• Guide CMC team with Regulatory updates, new requirements, and guidelines from the countries.
• Consolidate markets requirements for new products and participate in new initiatives processes.
• Generate a Global Pharmacovigilance system to be available for all countries and in parallel establish intercompany routine of product analysis based on information collected.
• Establish and maintain effective working relationships with other Phibro regulatory affairs team members.

• Minimum of 5 years in Biological RA , Ideally at least three years of industry experience, including experience in regulatory CMC (Part 2 – Quality).
• Minimum of a Bachelor’s degree in a relevant scientific or veterinary discipline.
• Global Managerial experience – is preferred.
• Experience with veterinary vaccines is preferred, but candidates with experience of veterinary pharmaceuticals may also be considered.
• Strong technical expertise in product quality/safety/efficacy (able to understand, critique and present information in a format appropriate to the audience)
• Frequent trips to Israel are required.

• Hebrew (Highly Advantage)
• English (required)
• Additional languages a plus