Job Description

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.
Our highly experienced teams in the US and Singapore span antibody discovery, pharmacology, production and clinical development. Together we aim to accelerate the journey of new drugs from concept to clinical care. For more information, please visit www.hummingbirdbioscience.com, and follow Hummingbird Bioscience on LinkedIn and Twitter.
ABOUT THE ROLE
The CMC Regulatory Science Senior Associate / Manager will report to the Head of Regulatory Science and be an active member of Regulatory Science department at Hummingbird Bioscience. The successful candidate will work closely with the CMC development groups and provide guidance on CMC regulatory strategy to optimize the development of Hummingbird Bioscience’s oncology pipeline. This is a global CMC regulatory role. You will be involved in defining the CMC regulatory strategy and in the preparation and submission of regulatory applications for clinical trials worldwide (including the US, EU, and APAC regions).
KEY RESPONSIBILITIES

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• Develop, execute, and communicate CMC regulatory strategies for investigational drug candidate(s) in compliance with global filing plans and regional regulatory requirements.
• 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

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• 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.
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 careers@hummingbirdbio.com.
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.