Regulatory Affairs Specialist – English Speaking

Über das Unternehmen

Novartis International AG is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. With a rich history of innovation, Novartis focuses on discovering new ways to improve and extend people’s lives through science-based innovation and digital technologies. Our diverse portfolio includes innovative medicines, generics and biosimilars, and eye care products, making us a leader in multiple therapeutic areas. Committed to ethical conduct and corporate responsibility, Novartis strives to be a trusted partner in healthcare.

Stellenbeschreibung

We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our team in Linz. In this crucial role, you will be responsible for ensuring the compliance of our products with national and international regulatory requirements, particularly focusing on the European market. You will manage the preparation, submission, and maintenance of regulatory documents, acting as a key liaison between our company and health authorities. This position demands a strong understanding of regulatory frameworks, meticulous attention to detail, and excellent communication skills, especially in English.

Hauptverantwortlichkeiten

• Prepare, compile, and submit high-quality regulatory dossiers, variations, renewals, and other submissions to health authorities (e.g., EMA, national competent authorities).
• Ensure all submissions are accurate, complete, and in compliance with current regulatory guidelines and internal company procedures.
• Act as a primary contact point for regulatory authorities regarding assigned products and submissions.
• Provide regulatory guidance and support to internal project teams (e.g., R&D, Medical Affairs, Marketing) throughout the product lifecycle.
• Monitor and interpret new and evolving regulatory requirements and guidelines, assessing their impact on company products and operations.
• Maintain and update regulatory databases and tracking systems with current product registration information.
• Participate in regulatory intelligence activities to stay abreast of the competitive landscape and regulatory trends.
• Coordinate and review responses to regulatory agency inquiries and deficiency letters.

Erforderliche Fähigkeiten

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline.
• Demonstrated understanding of European pharmaceutical regulatory frameworks and guidelines (e.g., EU Directives, ICH guidelines).
• Fluency in English (written and verbal) is essential for international communication and documentation.
• Strong organizational skills with the ability to manage multiple projects and deadlines efficiently.
• Excellent attention to detail and accuracy in documentation.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

Bevorzugte Qualifikationen

• Master's degree or Ph.D. in a relevant scientific field.
• 1-3 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry.
• Experience with electronic submission systems (e.g., eCTD).
• Knowledge of German is a significant advantage for local communication and understanding specific Austrian regulations.
• Familiarity with GxP regulations (GMP, GCP, GLP).

Vorteile & Zusatzleistungen

• Competitive annual salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous paid time off, including vacation, sick leave, and holidays.
• Opportunities for continuous learning, professional development, and career advancement.
• Employee assistance program and wellness initiatives.
• Modern office environment with state-of-the-art facilities.
• Contribution to a global mission of improving patient lives.

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