Regulatory Affairs Specialist

19 hours ago


Hong Kong, Central and Western District, Hong Kong SAR China Links International Full time

About the Role:

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We are seeking a highly skilled Regulatory Affairs & BioMed Tech Startup Management professional to join our team at Links International.

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The ideal candidate will possess a strong understanding of regulatory frameworks in the life sciences industry, with a proven track record of supporting the growth and development of biotech startups through operational management and technical expertise.

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Main Responsibilities:

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  • Provide operational support and account management for biotech programs, ensuring smooth development and execution.\
  • Facilitate connections for start-up companies with relevant service providers, including Contract Research Organizations (CROs), regulatory authorities, and quality system developers, to meet clinical trial and regulatory requirements.\
  • Coordinate the application process for regulatory funding and assist companies with regulatory submissions, ensuring all processes comply with internal and external guidelines.\
  • Serve as secretary for major program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring internal controls are in place for compliance.\
  • Conduct evaluations of program applications, arranging due diligence and assessment meetings, and providing input for continuous program enhancements.\
  • Contribute to the ongoing improvement of program SOPs and processes, supporting the continuous development of the ecosystem.\
  • Perform other related duties as assigned by the management team.\
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Requirements:

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  • A bachelor's degree in life sciences, biomedical sciences, biomedical engineering, or other related fields, or an equivalent qualification.\
  • At least 5 years of work experience, preferably in regulatory affairs or project management in the medical devices, pharmaceutical, or biopharma industries.\
  • Experience in CRO/CDMO management, protocol development, Investigational New Drug (IND) filing, and regulatory submissions (FDA, NMPA, etc.) is an advantage.\
  • Knowledge or experience in clinical trials and clinical affairs, particularly in medical devices and pharmaceuticals, is a plus.\
  • Strong interpersonal, communication, and presentation skills. A proactive, self-motivated, and results-oriented approach.\
  • Proficient in spoken and written English and Chinese, including Mandarin.\
  • Candidates with higher education or professional qualifications and less experience will also be considered.\
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About Us:

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Links International is a leading hub for technology and innovation, offering a dynamic and innovative work environment.

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What We Offer:

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  • A competitive annual leave and additional special leave.\
  • Comprehensive medical benefits, including dental and annual check-ups from day one, with extended coverage for dependents.\
  • Access to professional training and career development opportunities.\
  • Convenient transportation options, with a bus network connecting various locations across the city.\
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This is an exciting opportunity for an ambitious professional to contribute to the growth of biotech startups and make a significant impact in the life sciences sector.



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