Links International | Regulatory Affair

17 hours ago


hong kong, Hong Kong SAR China Links International Full time
Regulatory Affair - Assistant Manager (92561) Hong Kong

Job Title: Assistant Manager, Regulatory Affairs & BioMed Tech Startup Management

Location: Hong Kong

Job Description:
We are seeking a proactive and detail-oriented individual to join our team as an Assistant Manager for Regulatory Affairs & BioMed Tech Startup Management. The ideal candidate will play a key role in supporting the growth and development of biotech startups through regulatory affairs and operational management. This position will require a combination of technical expertise, project management skills, and a strong understanding of regulatory frameworks in the life sciences industry.

Key Responsibilities:

  • Program Management: Provide operational support and account management for biotech programs, ensuring smooth development and execution.
  • Stakeholder Coordination: Facilitate connections for the 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.
  • Regulatory Affairs Support: Coordinate the application process for regulatory funding and assist companies with regulatory submissions, ensuring all processes comply with internal and external guidelines.
  • Meeting Coordination: Serve as secretary for major program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring internal controls are in place for compliance.
  • Program Evaluation: Conduct evaluations of program applications, arranging due diligence and assessment meetings, and providing input for continuous program enhancements.
  • Standard Operating Procedures (SOP) Updates: Contribute to the ongoing improvement of program SOPs and processes, supporting the continuous development of the ecosystem.
  • Ad-hoc Duties: Perform other related duties as assigned by the management team.

Requirements:

  • 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.

What We Offer:

  • A dynamic and innovative work environment within a leading hub for technology and innovation.
  • A 5-day work week with 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.

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.

What you need to do now:
Click “Apply Now” if you are interested to be part of the team Alternatively, send your latest CV to for a confidential discussion of your career

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