Regulatory Affairs Director

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

BeiGene IL is seeking an experienced and energetic person to manage, evaluate, and complete regulatory affairs and to act as Israel Appointed Pharmacist consistent with company goals and local regulations. This individual will be responsible for timely planning and coordination of regulatory submissions, QP and QPPV local tasks. The Manager will represent IL Regulatory Affairs on cross-functional project teams, will provide input to the project team, and will manage regulatory submissions and regulatory archive.

Key Responsibilities:

• Ensure rapid submission and approvals of new products, dosage forms, and additional indications.
• Maintain licenses and variations, including labeling updates, CMC changes, site transfers, and artworks.
• Handle pruning/deregistration, temporary stock-out, and provide information for Health Care Providers.
• Review and submit promotional materials in accordance with local regulations and BeiGene standards.
• Coordinate and ensure quality responses to Health Authority questions.
• Support QA & logistics global departments with related issues (e.g., temporary stock-out, storage requirements).
• Ensure compliance with Good Distribution Practices (GDP) and Good Manufacturing Practice (GMP) for the import of pharmaceutical products.
• Support the regional Quality Head in implementing and maintaining the quality management system for imported products.
• Conduct batch verification and release of imported pharmaceutical products in compliance with Israeli regulatory requirements.
• Assist in the investigation and management of Non-Conformances (NC) and the development and implementation of Corrective and Preventive Actions (CAPA).
• Evaluate and approve temporary exportations, ensuring adherence to quality standards.
• Review and maintain documentation relevant to import activities, including import permits, batch records, and quality reports.
• Conduct supplier evaluations and audits to ensure compliance with quality and regulatory requirements.
• Participate in internal audits and facilitate inspections by regulatory authorities.
• Provide training and support to staff regarding quality assurance protocols and regulatory compliance specific to imported products.
• Integrate and lead processes in the quality department such as handling customer complaints, conducting quality audits for suppliers, managing changes and deviations, updating procedures, and performing risk management.
• Work with various stakeholders both domestically and internationally.
• Participate in global projects related to quality.
• Stay current with changes in regulations and ensure the company adapts accordingly.
• Ensure the collection, reporting, and handling of safety information associated with BeiGene products according to global and local regulatory requirements.
• Maintain oversight of safety risk management and all other pharmacovigilance (PV) activities.
• Ensure PV compliance and inspection readiness across all affiliate functions.
• Act as BeiGene’ s contact point for Pharmacovigilance Inspections in Israel.
• Manage Individual Case Safety Reports (ICSR) from all relevant sources.
• Ensure safety queries, significant safety issues, and crisis management are performed according to global and local requirements.
• Prepare and manage safety reports.
• Collaborate with relevant functions internally to ensure adequate awareness and education of BeiGene Israel employees regarding safety matters.
• Oversee the implementation of Risk Management Plans

Skills and Experience:

• Understanding of the pharmaceutical industry and legal framework.
• At least 4-5 years of experience in Regulatory Affairs from Pharma and a minimum of 2 years as Appointed Pharmacist.
• A minimum of 2 years' experience in the pharmaceutical industry as QP and Quality Assurance background
• Experience in Drug Safety and familiarity with relevant regulations (PV).
• Preferred experience in the pharmaceutical industry as QPPV or member of PV function
• Experience interacting with the Ministry of Health.
• Experience with labeling changes.
• Strong knowledge of Israeli pharmaceutical regulations and standards regarding import and global relevant regulations and guidelines.
• Proficient in Hebrew and English.
• Proficiency in various computer programs

Education Required:

• IL Pharmacist degree, QP certification recognized by the Israeli Ministry of Health.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.