Links International | Regulatory Affair
17 hours ago
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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