Senior Manager, Global Regulatory Affairs Strategy

Position Summary Join our team as a Senior Manager in Global Regulatory Affairs, where you will play a pivotal role in shaping global regulatory strategies. You will be responsible for planning and executing submissions for investigational and marketed prescription drugs, while managing lifecycle activities aligned with our Global Regulatory Lead (GRL). Key Responsibilities Lead the development of comprehensive global regulatory strategies for projects, ensuring timely and effective submissions. Research and gather regulatory intelligence, assessing prior approvals and health authority feedback to inform strategic options for Otsuka products. Communicate complex regulatory requirements and challenges to the GRL, global regulatory team, and cross-functional teams. Collaborate with the global regulatory team to create regulatory plans and address any global regulatory issues or health authority queries. Oversee the preparation of regulatory submissions including INDs, CTAs, amendments, and NDA responses, ensuring high-quality documentation. Act as the primary point of contact with health authorities, representing the interests of the Global Regulatory Affairs team. Participate in project team meetings, providing regulatory insights and guiding actions to meet project timelines. Effectively manage internal teams and external consultants to support assigned projects. Work with various functional teams to compile necessary data for timely submissions. Contribute to department initiatives aimed at enhancing efficiency and quality. Knowledge, Skills, and Qualifications Minimum of 5 years of experience in regulatory affairs or related fields within the pharmaceutical or healthcare industry (Master’s degree preferred). Proficient in preparing global regulatory submissions (IND, CTA, NDA/BLA, MAA). Strong communication skills, with ability to articulate regulatory complexities clearly. Thorough understanding of drug development processes and relevant regulations (FDA, ICH, etc.). Demonstrated ability to lead cross-functional teams, prioritize tasks, and manage project lifecycle effectively. Experience with Microsoft Office and familiarity with electronic document management systems is essential. In this role, you will be trusted to drive impactful decisions, champion customer and patient needs, and collaborate respectfully with diverse teams to foster innovative solutions. If you are results-oriented and looking to grow professionally in a dynamic environment, we would love to hear from you! Travel Requirement

- Expect approximately 20% travel. Otsuka's Commitment Otsuka is committed to equal opportunity employment. We welcome applicants from diverse backgrounds and do not discriminate on any legally protected characteristic. Join us in making a difference in global healthcare!