Regulatory Affairs Specialist
19 hours ago
About the Role:
\We are seeking a highly skilled Regulatory Affairs & BioMed Tech Startup Management professional to join our team at Links International.
\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.
\Main Responsibilities:
\- \
- 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.\
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.\
About Us:
\Links International is a leading hub for technology and innovation, offering a dynamic and innovative work environment.
\What We Offer:
\- \
- 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.\
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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