Regulatory Affairs Intern

Hkg - Hong Kong Island - Hong Kong (lee Garden Two)entry

OtherRegulatory Affairs

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OtherRegulatory Affairs

Job Description

The Pharmacy Internship Training Programme will be conducted under the supervision of the Regulatory Affairs Team for graduates of local accredited Bachelor of Pharmacy ("BPharm") Programs offered by The University of Hong Kong ("HKU") and The Chinese University of Hong Kong ("CUHK").

The Pharmacy Internship Training Programme covers various aspects across different departments, including:

· Regulatory Affairs – To handle New Product Registration and product Registration Life-Cycle Management, with strategic planning for new launch and/or implementation of post-approval variation; Provide support to cross-functional teams such as Tender and In-Market Quality support.

· Medical Affairs – To handle inquiry & patient program, experience to visit with HCP & symposium.

· Pharmacovigilance – To handle AE reporting & if there is a need, to verify the data.

· Others – Attending Drug Office seminar and/or Medical Device seminar, opportunities to work with different stakeholders, e.g. DOH officers, CPO, Legal Advisor etc.

Adverse Event Report, Audits Compliance, Collaborative Development, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmacovigilance, Policy Implementation, Product Registrations, Records Retention Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Strategy Development, Stakeholder Engagement, Strategic Management, Strategic Planning