Job Description

Dr. Samuelov – Better Pharma is requiting a Regulatory Affairs coordinator, positioned in Ra’anana head office.

You will be working with various internal and external, national and international functions in order to develop, maintain and support the DRA strategy of the organization.

Activities And Responsibilities

Medicinal products:

• Preparation of submissions of new drug applications, renewal drug applications and variations of a pharmaceutical product to the Ministry of Health.
• Preparation of submission of requests for advertising of OTC and Rx drugs and assure advertising compliance.
• Preparation of submission of updates to physician PI and patient inserts and assure implementation in marketed product.
• Review and approve medical and marketing materials for HCP and Patients.
• Preparation of submission of updates to artwork (carton, label, blister, leaflet etc) and assure implementation in marketed product.
• Provide the Qualified Person with the most up-to-date product registration documentation and approved packaging materials.

Homeopathic products, cosmetics, medical devices, medical cannabis

• Submissions of new registration applications, renewal applications and variations of to relevant departments of the Ministry of Health.
• Submission of updates to physician PI and patient inserts and assure implementation in marketed product (when applicable).
• Review and approve medical and marketing materials for HCP and Patients.
• Submission of updates to artwork (carton, label, blister, leaflet etc) and assure implementation in marketed product.
• Batch release of homeopathic products and medical devices.

Skills And Competencies

• He/ She must also be proficient and have vast body of knowledge regarding the quality, safety, control, and efficacy related to his products.
• Highly organized and structured.
• Good communication, problem solving and time management skills. Able to prioritize workload to make the most of time and resources
• English must be fluent

Mandatory requirements:

• Bachelor of Science degree – Mandatory
• At least 1 year of experience in regulatory affairs / QA position.