2个职位: 招聘信息 国际/商品贸易秘书
Personal Assistant to Managing DirectorID:61080
3,000 MYR ~ 4,000 MYRPerai工作内容
Job SummaryProvide administrative and personal support to the Managing Director and assist with daily management matters.Responsibilities• Manage the Managing Director’s schedule, appointments, and meetings.• Prepare documents, reports, letters, and presentations.• Arrange meetings, travel, and appointments.• Follow up on matters assigned by the Managing Director.• Coordinate with departments, customers, suppliers, and business partners.• Handle confidential documents and information.• Assist the Managing Director with daily administrative matters.• Perform other duties assigned by the Managing Director.
福利制度
- Annul Leave 10 days onwards
- Medical Leave 14 days onwards
- Hospitalization leave 60 days
- Insurance Coverage
- Panel Clinic
- Performance Bonus
- Yearly IncrementRegulatory Affairs ExecutiveID:60895
6,000 MYR ~ 8,000 MYRDamansara Heights工作内容
Job PurposeTo sustain the sales and operations of the company, the Regulatory Affairs Specialist is:- Fully responsible for timely filing drug applications for new and existing products for Malaysia and Singapore- Responsible also for supporting the development, and evaluation of consumer products aimed at the market.- Responsible for supporting marketing activities for Malaysia and Singapore with his/her pharmacy knowledge such as safety and product information.- Responsible for supporting regulatory activities for Brunei.Detailed Duties, Responsibilities- Liaise with the government office, authorities and regulatory consultant(s) on matters pertaining to regulatory activities, licenses and permits to developing new and existing products. Products include drugs, medical devices, general goods, food and cosmetics.- Develop and recommend the best regulatory strategy for submissions, including regulatory timelines, while discussing with the head office in Japan during the planning phase for new products to achieve timely and cost effective clearance/approval.- Review technical dossier of new products application and prepare additional documents where necessary to ensure a smooth register.- Conduct timely approval of new product- Conduct renewal of existing product licenses, manufacturing site qualification, post-approval variations, and other applications in accordance with requirements of the government office.- Maintain the appropriate GDP for drugs, medical devices and cosmetics.- Evaluate the existing supply chain and advise on necessary changes to meet the guidelines- Manage and lead the implementation of various GDP training modules and programs- Manage and respond to internal and external regulatory audit.- Handle post-marketing activities and pharmacovigilance. Then report requirements of company and product licenses to the government periodically or when it is required.- Review advertising, package labeling and promotional items to ensure regulatory compliance and give advice to marketing staff at local or Japan, if it is necessary to amend copy or any explanations. Then obtain permits from government office and authorities, if necessary.- Register and renew the company licenses.- Prepare a monthly report on pharmacovigilance for the head office and report it to the President.- Provide guidance to project team members regarding regulatory compliance issues by maintaining an up-to-date understanding of government office, regulations and organizational structure and potential changes.- Build and maintain relationships with key regulatory officials influencing regulations, to achieve positive and timely outcomes for product approvals.- At the request of the head office, prepare the regulatory procedures and necessary documents for applying to other countries.- Identify regulatory process improvements and work to improve and implement robust processes.- In case any quality complaints are reported from the market、report the details to the head office in Japan following the designated report flow and format. - Others, if any instructed.
福利制度
• Transport Allowance RM1,000
• Parking: Claim by receipts.
• Company Phone
• Travel expenses (To Outstation/ Oversea) for toll, parking, hotel accommodation and flight: Claim by receipts.
• Medical Claims RM2,500/year (including dental and optical)
• Travel expense (To outstation) Petrol: Claim by mileage - RM 0.55/ km
• Medical and Hospitalization: Insurance coverage (Up to RM 60K per annum)
• Annual Leave: 1st to 2nd Year - 12 days, 3rd year – 14 days, 4th year – 16 days, 5th year – 18 days and from 6th year and onwards – 20 days.
• Yearly performance bonus (Average 2-3 months)