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Assistant Manager, IncuBio (Regulatory Affairs & BioMed Tech Startup Management)
Salary undisclosed
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The Position
• Provide account management and operational support of Biotech Incubation Program (IncuBio) and its development
• Facilitate the connection for incubatees with CROs and relevant services providers for quality system development / IIT / clinical trial / regulatory requirements / regulatory submission
• Coordinate with IncuBio companies applying the regulatory affairs funding under the IncuBio program
• Handle regulatory funding panel assessment meeting and serve as secretary of IncuBio major meetings to ensure internal controls are in place for compliance
• Conduct evaluations of IncuBio Programme applications e.g. arranging various client meetings, due diligence meetings, panel assessment meetings, milestone assessment meetings and other activities related to ecosystem development
• Support IncuBio programme continuous enhancement and SOP updates
• Perform any other duties as assigned
Requirements:
• A bachelor's degree in life science, biomedical science, biomedical engineering or other related disciplines or equivalent
• 5 years work experience, preferably with regulatory affairs or project management in medical devices / pharma / biopharma industry
• Experience in CRO / CDMO management, protocol development, IND filing, FDA/NMPA submission would be an advantage
• Knowledge or experience in clinical trials and clinical affairs for medical devices and pharmaceutics and a plus
• Proactive, outgoing and positive attitude with ability to develop effective relationship, self- motivated and results oriented
• Good team player with strong sense of responsibility and excellent interpersonal and presentation skills
• Good command of spoken and written English and Chinese including Mandarian
• Higher education or professional qualifications with less experience will also be considered
What We offer
• Unique Work.Live.Play.Learn culture in Hong Kong’s largest Innovation & Technology ecosystem
• 5-day work week, attractive annual leave and additional special leave
• Medical benefits including dental and annual check-up from Day-1, with extended coverage to dependent(s)
• Professional training and career advancement opportunities
• Accessible to various bus service with network across different locations in HK
Interested parties please submit your application by clicking “Apply Now”. Commencing position will be commensurate with qualifications, relevant experience, and competencies.
The application will remain open until the position is filled. HKSTP reserves the right not to fill the position.
Personal data provided will be treated in strict confidence and used for recruitment purpose only. All personal data collected will be used strictly in accordance with employer’s personal data policies, you can refer to the Corporation’s Privacy Policy Statement at https://www.hkstp.org/privacy-policy/
Applicants not invited for interview within 6 weeks may consider their applications unsuccessful. Personal data of unsuccessful applicants will be retained for a maximum of two years counting from the date the vacancy has been filled.
About Hong Kong Science & Technology Parks Corporation
Hong Kong Science and Technology Parks Corporation (HKSTP) was established in 2001 to create a thriving I&T ecosystem grooming 13 unicorns, more than 15,000 research professionals and over 2,000 technology companies from 28 countries and regions focused on developing healthtech, AI and robotics, fintech and smart city technologies, etc.
More information about HKSTP is available at www.hkstp.org.
• Provide account management and operational support of Biotech Incubation Program (IncuBio) and its development
• Facilitate the connection for incubatees with CROs and relevant services providers for quality system development / IIT / clinical trial / regulatory requirements / regulatory submission
• Coordinate with IncuBio companies applying the regulatory affairs funding under the IncuBio program
• Handle regulatory funding panel assessment meeting and serve as secretary of IncuBio major meetings to ensure internal controls are in place for compliance
• Conduct evaluations of IncuBio Programme applications e.g. arranging various client meetings, due diligence meetings, panel assessment meetings, milestone assessment meetings and other activities related to ecosystem development
• Support IncuBio programme continuous enhancement and SOP updates
• Perform any other duties as assigned
Requirements:
• A bachelor's degree in life science, biomedical science, biomedical engineering or other related disciplines or equivalent
• 5 years work experience, preferably with regulatory affairs or project management in medical devices / pharma / biopharma industry
• Experience in CRO / CDMO management, protocol development, IND filing, FDA/NMPA submission would be an advantage
• Knowledge or experience in clinical trials and clinical affairs for medical devices and pharmaceutics and a plus
• Proactive, outgoing and positive attitude with ability to develop effective relationship, self- motivated and results oriented
• Good team player with strong sense of responsibility and excellent interpersonal and presentation skills
• Good command of spoken and written English and Chinese including Mandarian
• Higher education or professional qualifications with less experience will also be considered
What We offer
• Unique Work.Live.Play.Learn culture in Hong Kong’s largest Innovation & Technology ecosystem
• 5-day work week, attractive annual leave and additional special leave
• Medical benefits including dental and annual check-up from Day-1, with extended coverage to dependent(s)
• Professional training and career advancement opportunities
• Accessible to various bus service with network across different locations in HK
Interested parties please submit your application by clicking “Apply Now”. Commencing position will be commensurate with qualifications, relevant experience, and competencies.
The application will remain open until the position is filled. HKSTP reserves the right not to fill the position.
Personal data provided will be treated in strict confidence and used for recruitment purpose only. All personal data collected will be used strictly in accordance with employer’s personal data policies, you can refer to the Corporation’s Privacy Policy Statement at https://www.hkstp.org/privacy-policy/
Applicants not invited for interview within 6 weeks may consider their applications unsuccessful. Personal data of unsuccessful applicants will be retained for a maximum of two years counting from the date the vacancy has been filled.
About Hong Kong Science & Technology Parks Corporation
Hong Kong Science and Technology Parks Corporation (HKSTP) was established in 2001 to create a thriving I&T ecosystem grooming 13 unicorns, more than 15,000 research professionals and over 2,000 technology companies from 28 countries and regions focused on developing healthtech, AI and robotics, fintech and smart city technologies, etc.
More information about HKSTP is available at www.hkstp.org.
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