งาน ใกล้ ARL สุวรรณภูมิ 101 ตำแหน่ง

กรุณาระบุอีเมล์ที่ถูกต้อง
บันทึกข้อมูลเรียบร้อยแล้ว, คุณจะได้รับข่าวเกี่ยวกับตำแหน่งงานใหม่ๆ ตามที่คุณลงรายละเอียดไว้ หรือใกล้เคียงกัน
19 พฤศจิกายน 2562
รหัสงาน: BK-158244
Regulatory Affairs Specialist (1 year Contractor)

Working day  :  Monday – Friday

Working time : 8:00 AM ‐ 5:00 PM

Overall Responsibility

Providing input into the global regulatory strategy and identifying country requirements for successful regulatory filings for new products/ license renewal including regulatory maintenance throughout product life cycle within the countries in collaboration with MD&D and other regulatory activities assigned by supervisor.

Scope of Jobs

  • Requisition required document from source company and provision of supported document to the local regulatory teams in Myanmar, Cambodia and Laos for local health authorities' submission for new products, variations or re-registration to existing product in line with Marketing launch plans.
  • Maintain departmental and source company databases of regulatory approvals
  • Liaise and establish cooperative relationships with source company regulatory colleagues to ensure understanding of regulatory requirements in Myanmar, Cambodia and Laos (if any) request the documentation required for registration submissions.
  • Build constructive relationships with the local health authority and executes regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
  • Maintain and awareness of new legislation, policies and guidelines of Myanmar, Cambodia and Laos impacting product portfolio with local regulatory representatives.
  • Contribute to RA Team meetings to learn from colleagues, share experiences and best practice.
  • Engage Marketing colleagues to strategize new product regulatory pathways, line extensions and changes to currently approved products and actively accelerate launch timelines.
  • Manage interactions with stakeholders and distribution centers as required to ensure product supply is not disrupted. 

Qualification:

  • Bachelor's degree or equivalent in Science related like Pharmacy, Bio-Engineering, Med Tech, international program graduated would be a plus;
  • Familiarity with the regulatory systems and product registration requirements in Myanmar, Cambodia and Laos would be a plus; 
  • Excellent verbal and written communication skills - proficiency in written and oral English is highly required;
  • Demonstrated ability to handle multiple projects;
  • Enthusiasm for Regulatory Affairs: achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment;
  • Base in Lardkrabang office and can be remotely work, if necessaries.

รายละเอียดงาน:

สวัสดิการ
  • ทำงานสัปดาห์ละ 5 วัน
  • เงินโบนัสตามผลงาน
  • บริการรถรับส่งพนักงาน
  • ประกันสุขภาพ
  • สิทธิการเบิกค่าทันตกรรม

Johnson & Johnson (Thailand) Limited
https://www.jnj.com/
Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. Johnson & Johnson has more than 250 companies located in 57 countries around the world. Our Family of Companies is organized into several business segments comprised of franchises and therapeutic categories; Consumer , Medical Devices & Diagnostics , and Pharmaceuticals. If you are looking for more than a job, and are inspired by the opportunity to create the future to bring quality of life to the world, we invite you to build your career with us.

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