Description Overview

Scope of the Role

• Maintenance of local QMS (incl. verification and development of the current system)
• Conduct of self-inspections and audits
• Change management process, deviations, CAPAs, outsourcing activities, etc
• Provide trainings to relevant stakeholders
• Obtaining approval for import of products and batch release
• Participation in inspections
• Ability to manage pharmaceutical warehouse
• Oversight for some regulatory licencing and post marketing regulatory activities.
• Ensuring strategies and relationships with internal (e.g. GPS, CQA, Global Supply, CSCI Marketing, Commercial) and external stakeholders
• Ensuring company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the region.

Experience Required

• Minimum 4 years’ experience from the pharmaceutical/life science/selfcare industry, with a focus on quality and regulatory affairs applying to OTC/ self-care products . Understanding of pharmacovigilance will be an added value.
• A scientific degree in a pharmaceutical discipline.
• Experience in conducting of specialized examination of registration dossiers for medicinal products.
• Experience in preparation of documents for the procedure of confirming the compliance of the conditions of production of medicinal products with the requirements of GMP in accordance with the requirements of the order of the Ministry of Health
• Experience in handling of registration dossier.
• Experience in the processes of registration, re-registration and making changes to the registration dossiers for finished medicines, dietary supplements, medical products.
• Knowledge of the regulatory framework of the pharmaceutical industry, in [articular the requirements of GDP and ISO 13485 and ISO 22716
• Person speaking Fluent English (at least advanced level)
• Ability to manage cross-functional projects efficiently.
• Proactive and results-oriented: takes ownership, can work independently, has a can-do attitude