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บริษัท ไบโอจีนีเทค จำกัด

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Apr 3, 2025

Regulatory Affairs & Pharmacovigilance Pharmacist

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Phra Khanong, Bangkok

salary iconSalary
salary iconNegotiable
number of positions iconVacancies
number of positions icon1 อัตรา
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Job Descriptions
Responsibilities: •Manage all activities related to Regulatory Affairs (pre-submission, submission, and life cycle maintenance) of the medical devices and other products as assigned by RA head. •Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to questions and/or comments from FDA authorities. •Monitor progress of variations approval process with the regulatory authority. Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals. •Review all current approved packaging materials to ensure the contents are in accordance with local regulatory requirements, local regulatory approved documents, and reference document. Development of the packaging material artworks those are aligned with the local regulatory approval and other related forms/activities as requested by the supplier in order to support the related functions in a timely manner. •Ensure compliance of regulatory requirements, company & principles policies. Keep up to date for law & regulations knowledge related to regulatory works. •Update and maintain regulatory databases. •Provide Hospital Bidding & Enlisting document to marketing as requested •Consult, review, and advise on promotional materials to published under marketing and sales activities such as advertising, leaflets, sales promotion programs and all activities related to Regulatory Affairs •Facilitate communication between cross functional stakeholders to make the company meet the targets. •Cooperate with all related functions and concerned parties for PV and medical information management of medical devices and other products as assigned by RA head. Interested applicants are invited to send application with updated resume indicating qualifications and experience, expected salary by email: jidapab@biogenetech.co.th
Qualifications
  1. Bachelor’s degree in Pharmaceutical Science or Pharmacy
  2. Bachelor’s degree in Sciences
  3. 1-2 Year experiences in area of regulatory affairs for medical device, food and dietary supplement will be an advantage.
  4. Good command of Thai and English in writing, listening, and speaking
  5. Good computer skills in Microsoft Word, Excel and PowerPoint
  6. Sense of urgency, ability to manage priorities under pressure and be able to multi-tasks with priorities as assigned by RA head.
  7. Understands business needs and impact of regulatory issues
  8. Strong interpersonal skills, enthusiastic and a team player with positive attitude (Can-do attitude) and proactive working.
  9. Strong communication skills – both oral and written and proficiency in English and Thai.
  10. Well-organized, problem solving, hard-working and high contribution to the team and the company.
BenefitsSee all Benefits.
How to apply
Interested applicants are invited to send application with updated resume indicating qualifications and experience, expected salary by email
Contacts
บริษัท ไบโอจีนีเทค จำกัด
Email : biogene14_64@trustmail.jobthai.com (Email for job application & inquiry)
Website : http://www.biogenetech.co.th/
Location
Bang Chak Phra Khanong Bangkok
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