Associate Director

**Associate Director / Director, Regulatory Science - Hummingbird Bioscience**

Full-time position -SG based location

**ABOUT HUMMINGBIRD BIOSCIENCE**

Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity. At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic.

**ABOUT THE ROLE**

**KEY RESPONSIBILITIES**
- **Hands-On Implementation**: Actively engage in the drafting, reviewing, and coordination of regulatory documents, ensuring accuracy and timeliness. This role requires both strategic oversight and a willingness to be directly involved in execution.
- **Lifecycle Maintenance of Submissions**: Manage post-submission activities including regulatory amendments, protocol and investigator brochure updates, and general IND/CTA maintenance across regions.
- **Vendor Oversight**: Manage regulatory vendors (e.g., CROs, publishers, consultants), ensuring deliverables are of high quality, aligned with internal expectations, and meet timelines.
- **Adaptability and Problem-Solving**: Operate effectively within a dynamic startup environment where roles and priorities may evolve. Be prepared to handle emerging challenges and adjust plans as necessary.
- **Cross-Functional Collaboration**: Work closely with internal teams—including clinical operations, medical, safety, CMC, and nonclinical—to align regulatory activities with program goals and timelines. Ensure consistent communication across functions to support submission readiness.

**ESSENTIAL QUALIFICATIONS**
- **Educational Background**: Bachelor’s degree in a relevant scientific or regulatory field is required; a Master’s degree is preferred.
- **Experience**: Minimum of 7 years of experience in regulatory science, clinical trial submissions, or related roles, with demonstrated progression in responsibility.
- **Communication**: Strong written communication and presentation skills, including the ability to independently prepare clear, well-structured regulatory slides for cross-functional discussions.
- **Regional Experience**: Experience in dealing with regulatory submissions in the US and Asia-Pacific region is highly desirable. Experience with oncology trials is highly desirable. Prior experience with NMPA submissions is a plus.
- **Flexible and Adaptive Mindset**: Ability to thrive in an environment where processes are evolving and to adapt to shifting priorities.
- **Hands-On Approach**: A readiness to engage directly with operational tasks and ensure that strategic plans are executed effectively.

**OUR MISSION & VALUES**

Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and living by our values: Excellence, Determination, Teamwork, Intellectual Integrity and Audacity.

**JOIN US AT THE FRONTIER OF DRUG DISCOVERY AND DEVELOPMENT**

We are looking for passionate and motivated individuals committed to solving important, complex problems. We are committed to the personal and professional development of our team and offer robust learning and development programs. Hummingbird Bioscience understands the need for flexibility for our team and offers a generous paid time off program with flexibility to support employees through different life stages. We invest in our team’s health by offering competitive benefits including health and dental insurance, and a comprehensive and holistic employee assistance program. We foster a more collaborative, productive, and sociable culture with on-site lunches and snacks. Finally, we believe in creating social impact beyond our business through corporate social responsibility initiatives.
- Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications._