Galapagos
Galapagos is a biotechnology company with operations in Europe and the U. S. , focused on transforming patient outcomes through innovative science and technology. The company specializes in developing small molecules and cell therapies targeting high unmet medical needs in oncology and immunology. Galapagos aims to anticipate and shape the future of healthcare by creating a deep pipeline of best-in-class therapies and ensuring that their innovations reach those who need them most. With a commitment to sustainability, trust, and transparency, Galapagos operates with a strong patient-centered approach and engages in meaningful collaborations and partnerships, including an alliance with Gilead. Their technology platforms enable scalable and agile discovery and development of differentiated medicines.
biotech • R&D • Medicine discovery • Medicine development • Pharmaceuticals
Regulatory Affairs CMC Director
March 19
Galapagos
Galapagos is a biotechnology company with operations in Europe and the U. S. , focused on transforming patient outcomes through innovative science and technology. The company specializes in developing small molecules and cell therapies targeting high unmet medical needs in oncology and immunology. Galapagos aims to anticipate and shape the future of healthcare by creating a deep pipeline of best-in-class therapies and ensuring that their innovations reach those who need them most. With a commitment to sustainability, trust, and transparency, Galapagos operates with a strong patient-centered approach and engages in meaningful collaborations and partnerships, including an alliance with Gilead. Their technology platforms enable scalable and agile discovery and development of differentiated medicines.
biotech • R&D • Medicine discovery • Medicine development • Pharmaceuticals
📋 Description
• Lead regulatory affairs for CMC in cell and gene therapy • Provide expertise in EU regulatory processes • Obtain and maintain regulatory approvals • Act as company representative with health authorities • Collaborate with partner companies on drug development • Develop regulatory CMC strategies • Manage regulatory CMC dossiers • Prepare for regulatory interactions with EU agencies • Ensure compliance with regulatory requirements • Adhere to company policies and procedures
🎯 Requirements
• Master’s Degree in health sciences, pharmacy, biological sciences, chemistry, or related field • 8 to 15 years of biotech industry experience • In-depth expertise in CMC and EU regulatory affairs • Knowledge of international regulatory affairs environment • Proven experience in Health Authority interactions • Strong organization skills and flexibility • Effective communication style and interpersonal behavior • Mature people management and coaching skills • Strong data gathering, problem-solving, and analytical thinking skills • Strong verbal and written communicator in English
🏖️ Benefits
• Competitive compensation package • Supportive work environment • Strong focus on health and well-being • Opportunities for growth and development • Culture of empowerment
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