Senior Regulatory Affairs Specialist

Responsibilities

• Ensure compliance with ICH, EMA, and FDA regulatory guidelines
• Support global regulatory applications, including new marketing authorizations, renewals, and variations for international markets (e.g., MENA, EMIA, LATAM, APAC)
• Prepare regulatory documentation in collaboration with cross-functional organizational units
• Perform dossier due diligence and maintain deep knowledge of regulatory dossiers
• Support local offices in obtaining necessary approvals
• Coordinate with teams to respond to regulatory agency inquiries and track response status
• Maintain databases for submitted applications, approvals, and market-specific regulatory requirements
• Participate in cross-functional teams and strategic meetings to ensure timely delivery of results

Requirements

• VSS or minimum 300 ECTS in pharmacy, chemical technology, chemistry, biotechnology, or a related field
• Excellent proficiency in English (both written and spoken)
• Proactive and solution-oriented mindset
• Detailed and systematic approach to tasks

Preferred Qualifications

• Experience in regulatory affairs
• Experience in drug analytics
• Experience in Quality Assurance (QA) or Quality Control (QC)

Benefits

• Generous annual leave and reward plans
• Flexible working hours (depending on the position)
• Access to tailored healthcare support
• Career development opportunities through the "Twist" platform, including learning programs and internal growth opportunities

About the Company

Teva is a leading innovative biopharmaceutical company driven by its world-class generics business. Whether through innovations in neuroscience and immunology or the delivery of high-quality medicines worldwide, we are dedicated to meeting patient needs now and in the future.