Regulatory Affairs Specialist

📋 Description

• Support the execution of regulatory activities for products within the assigned portfolio, in
• Contribute to the timely preparation, submission, follow-up, and maintenance of regulatory
• Support the management of complex or high-impact regulatory matters in collaboration with senior
• Support regulatory compliance and business continuity, helping to minimize supply interruptions and
• Prepare and support submissions for new marketing authorizations, variations, renewals
• Maintain product licenses and regulatory documentation in accordance with local requirements

🎯 Requirements

• University degree in Pharmacy or related careers with equivalent experience. A related health
• Intermediate English proficiency, typically equivalent to B1-B2. Able to read and understand
• Typically 2-3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Practical exposure to drug product registrations, lifecycle management activities, variations
• Working knowledge of local regulatory requirements and submission processes.
• Ability to prepare and review regulatory documentation with attention to detail and guidance from