Associate Director Director, Regulatory Science

Associate Director / Director Regulatory Science - Hummingbird Bioscience

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 Biosciences 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.

For more information please visit and follow Hummingbird Bioscience onLinkedInX (formerly Twitter) andYouTube.

ABOUT THE ROLE

The Regulatory Science Associate Director / Director will serve as a key member of the Regulatory Science team at Hummingbird Bioscience. This role will be responsible for developing and executing global regulatory strategies and ensuring timely preparation and submission to support clinical trials and regulatory interactions is a technical individual contributor role with cross-functional impact working closely with development teams external partners. The successful candidate will guide regulatory decision-making across development stages and contribute to both Clinical and CMC regulatory activities for a growing oncology pipeline.

KEY RESPONSIBILITIES

• Oversee Clinical Trial Submissions: Coordinate and oversee the preparation of clinical trial applications across multiple regions including the United States and Asia-Pacific. Ensure that all submissions are timely complete and meet relevant regulatory requirements. Support the preparation and submission of applications for regulatory designations (e.g. Fast Track Breakthrough Therapy Orphan Drug etc.
• 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 teamsincluding clinical operations medical safety CMC and nonclinicalto align regulatory activities with program goals and timelines. Ensure consistent communication across functions to support submission readiness.

ESSENTIAL QUALIFICATIONS

• Educational Background: Bachelors degree in a relevant scientific or regulatory field is required; a Masters 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 teams 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.

Are you ready to join us on our mission to discover and develop important new drugs for cancer and autoimmune disease Click on Apply for this Job to submit your application.

For further enquiries please email us at .

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 conditionsmarital status protected veteran status and other protected classifications.

Required Experience:

Director