Registration/Appointed Pharmacist for a global company

Registration/Appointed Pharmacist for a global company

Job Number: 27343

Description:

A global company is looking for a Registration/Appointed Pharmacist.

location: Hasharon Region, Israel

Responsibilities:

• Implementing regulatory strategies for medical products and supporting the registration of the company's products in the local authorities in Israel.
• Working with the local regulatory authorities regarding products in Israel.
• Supervision of applicable regulatory requirements and compliance with company standards and external standards.
• Creating appropriate communication within RA and with other functions.
• Analysis of regulatory gaps and proposal of solutions.
• Development and documentation of regulatory decisions and justifications.
• Ensuring that the regulatory strategies are aligned with the project teams and the country's business objectives.
• Review of promotional materials and SOPs for compliance with local and global regulations.
• Represent the RA function on assigned cross-functional project teams.
• Impact assessment of changes in regulations: for local businesses, functions and global RA.
• Documenting activities in the company's databases and systems and updating the database.
• Providing RA support for company products distributed by the company or by distributors.
• Representation of the Israel company in the local health authorities.
• Creating appropriate communication with other functions including SC, Quality etc.

Requirements:

• Certified registration pharmacist (approved by the Ministry of Health to act as a local RA pharmacist) - mandatory
• About 3 years of registration experience - mandatory (preferably from a global company)
• Certified pharmacist - an advantage
• High level English
• Experience with RIM is an advantage
• Good interpersonal interaction
• Ability to independently identify compliance risks and escalate when necessary