Roles & Responsibilities
Regulatory Affairs Manager
Hummingbird Bioscience builds revolutionary biotherapeutics through the application of proprietary biological insights and technologies. We are on a mission to unravel the complexities of human disease. Using systems biology, we find new and elusive drug targets and engineer breakthrough biotherapeutics to precisely intercept them, giving people hope for new treatments when all others have failed. This is a bold, new way of finding the right drugs for the right people.
Hummingbird Bioscience has built a pipeline of promising drugs expected to enter clinical trials in 2020. With locations in Singapore, Houston, Texas and South San Francisco, California, Hummingbird is well funded by venture capital and has established strategic collaborations with Cancer Research UK and Amgen. To learn more about our science, pipeline assets, and team, please visit: www.hummingbirdbioscience.com
About the Role:
Join Hummingbird Bioscience on our journey as we transition from an early-stage drug discovery company to a global leader in drug development. We are looking for a Regulatory Affairs Senior Associate/ Manager who will report to the Head of Regulatory Affairs and Quality Assurance and support the development and implementation of the companys Regulatory strategy.
Key responsibilities will include (but not limited to):
Support regulatory aspects within the product development process, with a focus on quality / CMC.
Assessment of regulatory data requirements and development of regulatory submission strategies.
Assist in the authoring, review and management of regulatory documentation for filing to Regulatory Agencies.
Providing regulatory inputs into Agency communications.
Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
Related experience in Regulatory Affairs: 4 to 6 years for a Manager.
Knowledge of Chemistry, Manufacturing and Controls (CMC) regulatory affairs or biopharmaceutical development experience.
Experience with Agency interactions and/or submissions in US, EU and China would be a plus.
Strong verbal and written communication skills with good attention to detail.
Good time management skills with the ability to effectively plan, priorities and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
Ability to find innovative solutions to complex problems and proactively seek out continuous improvement initiatives.
Excellent interpersonal skills with the ability to build strong relationships across internal and external partners.
Ability to work independently and with the flexibility to handle workflow in a fast-paced start-up environment
This is a full-time role based in Singapore.
To apply for this role, please apply on the careers page of our website with a maximum 2-page resume in PDF format, detailing your education and relevant experience, and a cover letter with your motivations for applying for this position.
Job Posts, Manager, Sciences / Laboratory / R&D on Aug 13, 2020