Regulatory Affairs Manager and Appointed Pharmacist

Join our Israeli Regulatory team as a Regulatory Affairs Manager and Appointed Pharmacist responsible for the registration and maintenance of Marketing Authorizations for medicinal products of assigned portfolio and related health regulated activities. You will be also involved in transversal regulatory activities in dedicated projects.

The team is involved in developing regulatory product strategies, leading regulatory efforts in the development stage and post marketing of drug products in the Israeli market.

Main responsibilities:

Serve as Appointed Pharmacist, responsible for all matters related to medical products as specified by the Ministry of Health
Ensure compliance with local Israeli regulations and requirements
Manage regulatory aspects of product lifecycle from development through post-marketing including:
- Define registration and maintenance plans
- Coordinate country dossier preparations
- Manage registration, renewal, and post-authorization variation processes
- Update product labels and packaging materials
- Contributing to the Global Regulatory Product Strategy
Review promotional and non-promotional materials for regulatory compliance
Implement processes and quality systems
Monitor changes in the regulatory environment in Israel
Build strong external network with Health Authorities and Trade Associations