Senior Associate

**Senior Associate / Manager, Global Regulatory Science (CMC)**

Regulatory, Singapore

**Senior Associate / Manager, Global Regulatory Science (CMC)**

(Full-time position - Singapore)

**ABOUT HUMMINGBIRD BIOSCIENCE**
- **Opportunity to work at the cutting edge of drug development**

Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets to improve treatment outcomes. We harness the latest advances in systems biology and data science to better understand and solve the underlying causes of disease and guide development of our therapeutics.

Enabled by our proprietary Rational Antibody Discovery platform, we discover antibodies against optimal yet elusive epitopes on important targets that have not been successfully drugged, unlocking novel mechanisms of action. We are advancing a rich pipeline of first
- and best-in-class precision therapies in oncology and autoimmunity, in collaboration with global partners in academia and industry.

**ABOUT THE ROLE**

**KEY RESPONSIBILITIES**
- Work with the internal teams, external partners, and contract manufacturing organizations (CMOs) to prepare and maintain CMC regulatory filings for multinational clinical trials.
- Support change management initiatives and develop post-approval submission strategies.
- Support the development of regulatory templates, SOPs, and internal processes for authoring and review of CMC submissions.
- Liaise with the CMC development groups and operational teams to ensure alignment of global regulatory strategies, timing, execution, and supply plans
- Attend project team meetings and provide CMC-related regulatory guidance to other functional areas, including manufacturing, quality, and operations

**ESSENTIAL QUALIFICATIONS**
- 2-3 years (Senior Associate), 4 years (Manager) or 5+ years (Senior Manager) of experience
- Experience with monoclonal antibodies. Experience with antibody-drug conjugates (ADCs) is an advantage.
- Experience in preparing, or coordinating the preparation of, CMC regulatory submissions (e.g., IND and CTA) for clinical trials, preferably in a global regulatory role. Experience with authoring CMC technical content is an advantage.
- Experience with clinical trial submissions. Previous exposure to US FDA, EMA and EU national competent authorities is an advantage.
- Knowledge of regulatory requirements, including ICH requirements and regional requirements and understanding of global regulatory trends.
- Strong written/oral communication skills, engaging approach, and perseverance with a drive for results.
- Able to work cross-functionally with diversified teams and external partners.

**OUR MISSION & VALUES**

Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and live 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, with continually updated learning and development programs. Hummingbird Bioscience understands the need for flexibility for our team, offering 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 health and wellbeing benefits including health and dental insurance, 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._