Biotech Regulatory Compliance Manager
5 hours ago
Job Description
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- About the Role: Links International is seeking a highly skilled and detail-oriented individual to join our team as an Assistant Manager for Regulatory Affairs & BioMed Tech Startup Management.">
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- Support the development and execution of biotech programs, ensuring smooth operational processes.">
- Establish connections between start-up companies and relevant service providers, facilitating access to resources and expertise.">
- Coordinate regulatory funding applications and provide assistance with regulatory submissions, ensuring compliance with internal and external guidelines.">
- Manage program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring effective communication and decision-making.">
- Evaluate program applications, conduct due diligence, and provide input for continuous program enhancements.">
- Contribute to the development of program SOPs and processes, driving continuous improvement and growth.">
- Perform other related duties as assigned by the management team.">
Requirements
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- A bachelor's degree in life sciences, biomedical sciences, biomedical engineering, or a related field, or an equivalent qualification.">
- At least 5 years of work experience in regulatory affairs or project management in the medical devices, pharmaceutical, or biopharma industries.">
- Experience in CRO/CDMO management, protocol development, IND filing, and regulatory submissions 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, with a proactive 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
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- A dynamic and innovative work environment within a leading technology and innovation hub.">
- 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 role offers a unique 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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