-       Person-In-Charge for Wholesale Dealer License (Ultimate Legal Responsible Person)

o    To ensure full compliance of the “Code of Practice for Holder of Wholesale Dealer Licence” by the Company.

o    To be responsible for ensuring the proper conduct and obligations required from a holder of Wholesale Dealer Licence.

o    To ensure all the company activities are in compliance with all relevant regulations/laws.

o    To develop and maintain SOPs for RA/QA/PV&MA as necessary.

-       Regulatory Affairs

o    To obtain and maintain Product Registration (Generic & NCE & Medical Device).

o    To maintain other licenses (Wholesales Dealer License, Antibiotic Permit).

o    To ensure the implementation of Change of Registered Particulars on time.

o    To review and approve new Packaging Materials prior to commercial use.

o    Responsible for ensuring that the registered particulars of each batch of the pharmaceutical products correspond exactly with the registered particulars of the products.

-       Quality Assurance

o    To be responsible for ensuring and certifying that each batch of the pharmaceutical products has been manufactured and checked in accordance with the Good Manufacturing Practice (GMP) Guide issued by the Pharmacy and Poisons Board of Hong Kong.

o    To be responsible for Shipment Release.

o    To manage Quality Complaints.

o    To handle local redressing.

-       Medical Affairs

o    To manage Pharmacovigilance activities

o    To review promotional materials to ensure the compliance with UMAO and HKAPI Code of Practice.

-       Others

o    To handle contracts/agreements related to RA/QA/PV&MA with external parties as necessary

o    To ensure all the company activities are in compliance with HKAPI Code of Practice

o    To provide training to all Marketing and Sales personnel regarding to the HKAPI Code of Practice

o    To assist Marketing Manager to prepare documents for government tender

o    To execute other ad-hoc matters

Position Qualifications and Experience requirements:

-          Education:

o    Bachelor Degree Holder and above

-          Experience:

o    Hands-on experience in RA, QA, MA &PV matters in pharmaceutical industry.

-          Competencies:

o    Proficiency in English in oral and written is a must

o    Excellent communication skills in oral and written

o    Strong demonstrable planning and execution skills

o    Strong project management skills

o    Good attention to details

o    Ability to engage internal & external stakeholders proactively

o    Ability to work independently

o    Adaptability to a complex business environment

o    Can-do attitude with strong problem solving skills

-          Eligibility:

o    Eligible to work in HK (Company will NOT provide support for Visa)

-          Others:

o    You will be provided opportunities to attend HKAPI RA/QA/MA&PV seminars