Senior ManagerAssociate Director, Regulatory Affairs Hematology & Oncology Early Development TA

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Job Summary

This role is responsible for end-to-end regulatory strategy and execution for new asset development and lifecycle management in Hematology/Oncology early development TA in China. This role will lead China regulatory interactions drive highquality submissions and approvals monitor changes to regulatory requirements and standards identify and mitigate regulatory risks and partner closely with R&D and commercial teams to enable successful drug development registration and commercial continuity in China.

Key Responsibilities:

• Develop and implement optimal regulatory strategies for new product development and life cycle management that align with global regional and China objectives.

• Prepare and deliver high-quality on-time regulatory submissions and secure approvals for CTAs NDAs/BLAs variations renewals etc. according to China requirements.

• Serve as the primary liaison with China regulatory agencies; Lead health authority interactions in China including briefing books face-to-face or virtual meetings and drive timely effective responses to health authority queries.

• Monitor and interpret changes in drug registration related regulations and guidelines in China; assess their impacts on existing products and future development programs.

• Identify regulatory risks and partner with cross-functional teams to develop and implement mitigation plans.

• Communicate regulatory strategy status timelines risks and business implications clearly to cross functional stakeholders.

• Collaborate closely with R&D QA/Compliance Supply Chain and Commercial teams to support drug development registration launch and lifecycle activities.

• Provide regulatory input on new regulations and guidelines and advise on their impact to drug development product launch and business continuity.

• Ensure regulatory activities in compliance with applicable regulations company policies and RA department SOPs.

Qualifications & Competencies

• Masters degree or above in chemistry pharmaceutics biology or a related life-science discipline.

• More than 5 years of regulatory affairs experience in a multinational pharmaceutical company.

• Experience in pharmaceutical R&D and leading regulatory strategy development for new assets. Strong familiarity with China regulatory systems and requirements.

• Growth mindset with strong collaboration communication and influencing skills in a matrix organization. Demonstrated leadership and learning agility.

• Excellent English communication skills (spoken and written); proficient computer skills and strong story telling/presentation abilities.

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