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Mô tả công việc
***Overall Job Purpose:
The Labelling Hub manager is responsible for regulatory activities pertaining to labelling updates for determined country/ies according to internal procedure and legislation applied to country/ies under her/his responsibility.
Provide Subject Matter Expert support to the Global Labelling Hub and Global Compliance Director, and other Stakeholders, with initiatives which impact, or may impact, labelling activities within the determined region and country/ies.
***Main Accountabilities:
• Liaise with Translation vendors as needed.
• General knowledge of preparing artwork from labelling text and the interface with Launch Management, Supply Chain and Quality teams.
• Manage all labelling variations through the Regulatory Information Management System and Trackwise Change control environment as needed to show compliance to global submission timelines and valid reason for delay.
• Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation.
• Communicate clearly issues and resolutions to peers and subordinates in a meaningful way.
• Ensure local labelling text is prepared right first time and on-time according to agreed company procedures and objectives.
• Onboards and manages regional assigned labelling associates.
• Advise Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
• Support regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission.
• Ensure that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation
• Ensures compliance with all relevant company SOPs
• Ensures maintenance of relevant systems according to relevant SOPs.
• Reports on agreed key performance indicators for set region.
• Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
• Performs other duties as assigned.
• Provide support during Medical and Regulatory Audits.
Yêu cầu
***BASIC QUALIFICATIONS
We are looking for professionals with these required skills to achieve our goals:
• Bachelor&039;s degree in Science, Medicine or Pharmacy, or another related field
• Labelling and Regulatory experience
• Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge
• Highly developed interpersonal, presentation and communication skills with advanced English language capability
***PREFERRED QUALIFICATIONS
If you have the following characteristics, it would be a plus:
• Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
• Understand GLC requirements/ processes and EU/ US regulatory requirements.
• Master&039;s Degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
• The ability to influence effectively in a matrixed, cross functional team environment
Quyền lợi
13th month salary, Performance Bonus
Annual leave
Thông tin khác
Thông tin cơ bản
Địa điểm: Hồ Chí Minh
Mức lương:Thương lượng
Hạn nộp hồ sơ: 23-12-2022
Chức vụ: Trưởng Phòng
Hình thức: Đang cập nhật
Kinh nghiệm: Đang cập nhật
Số lượng: Đang Cập Nhật
Trình độ: Đang cập nhật
Thông tin chung
- Ngày hết hạn: 23/12/2022
- Thu nhập: Thương lượng
