Regulatory Pharmacist

Job Title: Appointed Pharmacist

Introduction to role

Are you ready to play a pivotal role in ensuring the registration and compliance of life-changing medications? As an Appointed Pharmacist at AstraZeneca, you will be responsible for registering our medications in accordance with Israeli regulatory requirements, pharmacy regulations, Ministry of Health procedures, and AstraZeneca's global policies. This permanent position requires relevant qualifications and experience to help us bring innovative treatments to patients in need.

Accountabilities

• Registration Management:

- Responsible for the registration of the company's products.

- Prepare and submit registration dossiers in CTD format according to ICH requirements and the Israeli Ministry of Health regulations.

- Maintain up-to-date registration data, including renewals.

- Ensure the company's product registration data is current according to global updates or Ministry of Health requirements, covering quality aspects (CMC), medical data, and packaging.

• Regulatory Compliance:

- Prepare and submit registration materials for approval by authorities within timelines set by the global company and Ministry of Health. Track approvals by the Israeli Ministry of Health and manage updates in company systems.

• Quality and Standards:

- Implement control mechanisms to ensure registration data integrity amidst process changes.

- Adopt high activity standards based on quality processes, comply with Israeli regulatory requirements, and lead the implementation of AstraZeneca's Good Regulatory Practice standards.

• International and Local Regulations:

- Stay updated with international ICH guidelines, European, and US FDA regulations. Maintain current knowledge of GRP standards.

- Stay informed on Israeli pharmaceutical legislation, procedures, and Ministry of Health regulations relevant to the role. Implement required updates as needed.

- Update the global parent company on Israeli regulatory requirements and changes, ensuring timely implementation.

• Liaison and Communication:

- Serve as the liaison between authorities, company management, and manufacturing sites in Europe, the US, and other regions as required.

- Support authorities, physicians, pharmacists, and customers by responding to inquiries related to product information and quality.

- Verify and ensure medical information published for medical staff and patients complies with registration conditions and regulatory requirements.

• Marketing and Compliance:

- Oversee and approve marketing activities in line with global company standards and Ministry of Health requirements.

- Provide partial backup for periodic monitoring roles, including safety reports (PBRER), signal monitoring, and monthly review of EMA and US authority websites, per Ministry of Health and AstraZeneca procedures.

Essential Skills/Experience

• Valid Ministry of Health license to practice pharmacy.

• Approval from the Ministry of Health to serve as an appointed pharmacist.

• Relevant education and experience.

• B.Sc. Pharm

• Pharmacist approved by the Israeli Ministry of Health

• Experience in product registration

• High performer, results-oriented with proven outcomes, proactive approach.

• Ability to work under pressure with no compromise on results, manage multiple responsibilities.

• Open-minded, able to adapt, entrepreneurial spirit.

• Proven stakeholder interaction skills, solid regulatory understanding.

• Ability to learn various therapeutic areas from different perspectives.

• Proficient in communicating across functions in a matrix structure, both internally and externally.

• Demonstrated teamwork and collaboration skills.

• Accurate, result-oriented, punctual, meticulous.

• High ethical standards.

• Proficient in English (spoken & written).

• High level of computer literacy.

• Responsible and accountable.

Desirable Skills/Experience

• Knowledge and experience in artwork creation (packaging)

• Knowledge and experience in safety reporting

• Knowledge and experience in managing quality systems

At AstraZeneca, we are dedicated to turning our drug development strategies into reality. Our team works at all stages of development to translate our life-changing science into medicines that deliver the best results for patients and healthcare professionals. We value innovation and creative thinking, encouraging our team members to ask questions, try new things, and identify better ways to promote our products. Our collaborative environment empowers quick decision-making and fosters a culture where diverse skills and experiences are harnessed to drive progress.

Ready to make an impact? Apply now to join our dynamic team at AstraZeneca!