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Associate Regulatory Affairs Manager
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Pharmaceutical
Full-time
Hong Kong
Posted 2 days ago
Posted 2 days ago
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Job Function
- Regulatory Affairs & Legal
Discipline
- Biochemistry
- Biological Sciences
- Biomedical Sciences
- Cell and Molecular Biology
- Medical Sciences
- Pharmacy
- Public Health
Years of Experience
- 0-3 years
Salary
- HKD 25,000-30,000 per Month
Job Details
Responsibilities
- Assist the team to obtain the PIC/S GMP certification.
- Monitor regulatory requirements and emerging trends in relevant markets. Provide actionable insights to the company regarding regulatory changes and their implications.
- Serve as point of contact for internal and external partners to ensure partnership goals are achieved and governance processes are respected.
- Assists in the definition of deliverables, requirements, expectations, and help set realistic targets/timeframes for different scenarios involving Clinical, Manufacturing, and Regulatory Affairs which can differ dramatically between the US, EU and Asia.
- Facilitates professional communication with internal and external stakeholders to ensure projects milestones are met, escalates as needed to deliver collaboration goals.
- Develops and maintains a comprehensive knowledge of each alliance partner and maintain timelines for deliverables and key milestones.
- Assist the management, with eventual development into leading, of a dynamic, fast-paced, and highly regulated projects throughout an international environment
- Distills and documents discussions and outcomes as meeting minutes for senior management to execute key business decisions.
- Perform other assigned tasks as needed.
Requirements
- Degree in Medical Sciences or related discipline
- Strong knowledge of PIC/S GMP manufacturing and regulatory regulations and requirements for pharmaceutical/biological products.
- 2-3 years in a project management, regulatory compliance or alliance management function covering the China markets.
- Experience in working at GMP biopharmaceutical or pharmaceutical manufacturing field is an advantage
- Ability to stay updated on regulatory changes and industry trends.
- Working experience in a highly regulated field and communication with external internal partners is a plus
- Fluent in both Mandarin and English languages (verbal, written and translation ability)
- Flexible working hours to meet geographical needs – occasional early days and late evenings are expected
- Ability to travel cross-border.
- Microsoft office (including powerpoint and excel)
- Ability to coordinate requests, meetings, and events
- Ability to prepare reports, proofread documents
- Experience in professional communication with external partners is preferred
About the Company
Overview
Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs in the world. The company was listed in the Main Board of the Hong Kong Stock Exchange on 29 April 2021.
Zhaoke Ophthalmology has a comprehensive drug portfolio of innovative and generic treatments covering six major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.
Zhaoke Ophthalmology is focusing on advancing towards the goal of product commercialisation, and achieve the objective of improving visual health in China through scientific research as soon as possible.