Senior Manager, Regulatory Strategy
Contribute to the Develpoment of Advanced Oncology / Immunology Therapeutics
Expand your Career in a Senior Regulatory Strategy Position
- The client is an industry leading pharmaceutical manufacturing company, that specializes in the development of crucial medicines in the field of immunology, oncology, infectious diseases and neuroscience
- Provide leadership in creating and executing proactive global regulatory strategies for product development, approval and registration, and support of future marketed products.
Lead the process for filing regulatory submissions.
Proactively build relationships and trust with key internal and external stakeholders and decision makers.
Develop and implement regulatory strategies, including regulatory risk management, ensuring that any RA issues are highlighted and addressed satisfactorily and in a timely fashion.
Able to Lead regulatory discussions regarding strategy for the product in charge with cross-functional teams.
Able to collaborate with Global Regulatory Strategy Group Director and move the work forward in the assigned disease area under the instructions/support from his/her report line.
Skilled in risk management on the business impact of his/her own department and other departments of regulatory and interaction strategies
Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.
Good communication skill, good presentation skills, good strategic thinking ability, good negotiation skills, good leadership skills, good problem-solving ability
- Fluent Japanese and English communication
- Opportunity to create and execute regulatory strategy for clinical studies across APAC region
- Contribute to the development and successful approval of biologics and immunotherapies to treat unmet medical needs in the fields of oncology, neuroscience, infectious diseases