Head of Regulatory Affairs, R&D, Shanghai/Beijing
Takeda · Shanghai
Job Description
Objective / Purpose:
The Vice President, Head of Greater China Regulatory Affairs is responsible for providing strategic regulatory inputs into drug development and oversight of registration, life-cycle management and maintenance of Takeda's pipeline and marketed products. The role will involve developing and implementing progressive regulatory strategies, ensuring compliance with regulatory requirements, managing interactions with regulatory authorities, leading the regulatory strategy team and partnering with internal stakeholders to contribute to Takeda’s mission.
- Lead the regulatory strategy team to develop and execute innovative regulatory strategies enabling product approval, including challenging timeline and life-cycle management with predictability, cross-functiona collaboration and flawless execution.
- Cultivate and continuously strengthen the regulatory strategy team, fostering a high-performance, inclusive environment anchored in Takeda’s leadership behaviors to consistently achieve outstanding results.
- In partnership with Global Regulatory Policy and Innovation, shape the external environment by proactively engaging with Regulatory Authority (i.e. CDE), industry organizations (i.e. RDPAC), and key stakeholders to influence evolving regulations and standards. Champion collaborative initiatives that anticipate future trends, address emerging challenges, and advocate for innovative regulatory approaches, ensuring that Takeda’s interests are represented and aligned with the global healthcare landscape. Drive thought leadership by contributing to policy development, participating in industry forums, and building strategic alliances that position Takeda as a trusted partner and leader in regulatory innovation.Proactively engage and align with GRA, and foster collaboration with all relevant stakeholders, including Commercial Business Unit, R&D Regional organization, Medical Affairs, Legal among others.
Accountabilities:
- Regulatory Strategy: Ensures the regulatory strategy team secures timely regulatory approvals for new products, and post-approval variations by developing innovative approaches, including providing regulatory inputs in a timely manner to de-risk drug development; and upholds rigorous compliance to maintain product licenses.
- Regulatory Guidance: provides expert regulatory inputs to cross-functional teams, including clinical trial, registration, manufacturing, and commercial to influence drug development and product commercialization. Risk management and fact-based decision supporting.
- Stakeholders Management: Builds and maintains strong trusting relationships with internal and external stakeholders including regulatory authorities, industry associations, and global, regional and local functions to enable teams to deliver the pipeline.
- External Regulatory Environment: anticipates industry trends and shape the external environment through partnership with partners with Global Regulatory Policy and Innovation (GRPI) to monitor new policies and regulations taken appropriate actions, when applicable, as well as activity participation in industry associations (i.e. RDPAC) as well as attending meeting with regulatory agencies.
- Compliance: ensures compliance with applicable regulatory requirements and company policies, including Good Regulatory Practices (GRP), Regulatory Compliance and Standard Operating Procedures (SOPs). Works with global and local teams to enable compliance with regulatory systems i.e. RIM
- People Management: Has the ability to manage resources in different locations in China and beyond (i.e. Beijing, China, Hong Kong), allocate resources strategically and drive organizational transformation. Exemplifies Takeda’s leadership behaviors and actively cultivates these qualities within the team. Leads, mentors, and cultivates a high-performing team by fostering a culture of excellence, collaboration, and continuous improvement, while inspiring and motivating team members, recognizing potential, and strategically aligning talent with the right roles to maximize impact and accelerate growth.
- Collaboration and Communication: fosters collaboration with global regulatory, regulatory CMC and global regulatory policy and innovation to deliver regulatory goals and objectives. Ensure cross-functional collaboration by helping team members to understand each other and bringing them together.
- Regulatory Operations: Enables agile ways of work and continually look to increase the efficiency of processes, ensures financial responsibility.
R&D Qualifications & Skills：
- Education: Bachelor’s degree in life sciences. Master’s degree and above is preferred.
- Experience: 12+ years of regulatory affairs experience in the pharmaceutical industry with a strong track record of successful regulatory strategy and product approvals. 10+ years in people/team management capacity.
- Regulatory Knowledge: In-depth knowledge of global and local regulatory requirements, including FDA, EMA, NMPA, and other regional regulatory agencies.
- Strategic Thinking: demonstrates enterprise-level strategic thinking by breaking apart complex challenges to develop innovative solutions. Proven ability to lead and inspire cross-functional teams, with excellent project management and organizational skills.
- Problem-Solving: demonstrates ability to think strategically, analyze complex issues, and develop innovative solutions.
- Communication: Strong written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
- Cultural Competence: Experience working in a global environment, with an understanding of cultural differences and regulatory nuances.