[Japan] Associate Manager, Global Regulatory Operations & Maintenance

Santen is a pharmaceutical company with a 130-year history specializing in ophthalmology. As a global company originating from Japan, we have bases in over 60 countries, providing various innovative treatments and digital solutions for eye health, and addressing social issues related to vision for people around the world. Global Regulatory Operations & Maintenance (GROM) is responsible for the global regulatory affairs and lifecycle management of Santen products, promoting timely approval acquisition and ensuring compliance while responding to changes in regulatory requirements. This position will lead and execute regulatory strategies and lifecycle management for assigned products, achieving high-quality submissions and optimal approval acquisition, while also contributing to the continuous improvement of regulatory operations and the development of the organization.

• Lead the preparation and submission of high-quality regulatory submission documents (including CMC, non-clinical, and clinical) for assigned products in the Asia region (currently excluding China and Japan)
• Coordinate responses to inquiries from authorities and promote rapid approval acquisition for new applications, renewals, and variation applications
• Manage regulatory requirements and ensure compliance throughout the entire product lifecycle in assigned markets
• Monitor and evaluate regulatory trends in each country/region and propose appropriate countermeasures
• Function as a core regulatory coordinator overseeing regulatory activities across multiple products and multiple markets
• Collaborate with internal departments, overseas sites, and external partners to promote effective regulatory affairs activities
• Contribute to the continuous improvement of regulatory processes and provide regulatory advice and guidance to stakeholders

• Bachelor's degree or higher in life sciences (pharmacy, chemistry, etc.)
• 5+ years of practical experience in regulatory affairs
• Understanding of regulatory requirements and submission processes in the Asia region
• Experience in regulatory submission and lifecycle management operations
• Excellent project management skills with the ability to proactively drive tasks while managing multiple responsibilities
• High communication and stakeholder management skills (including experience in cross-functional collaboration)
• Business-level English proficiency (reading, writing, and speaking) necessary for global operations

Career Building at Santen

A career at Santen is an opportunity for you to make a difference. Through the long-term vision shown in "Santen2030," Santen aims to become a social innovator that meets the social and economic needs of people with visual impairments. To achieve this, we leverage diverse talents with team members around the world, providing flexible working styles and an inclusive work environment. As a result, we discover new solutions and drive understanding of patients and innovation in treatment. The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and providing a safe and inclusive physical and virtual workplace for every team member. All employment is based on business needs, role requirements, and individual skill sets, regardless of race, color, ethnicity, origin/ancestry, religion, sexual orientation, gender, gender identity/expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.