Regulatory Affairs Manager (Pharmaceutical Products) / ผู้จัดการด้านการขึ้นทะเบียนผลิตภัณฑ์ยา

Regulatory Affairs Manager (Pharmaceutical Products) (50K-75K) (SDG-51174)
<Job Responsibilities>
 Act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation
 Studying scientific and legal documents
 Gathering, evaluating, organizing, managing and collating information in a variety of formats
 Ensuring compliance with regulations set by Thai FDA
 Planning, undertaking and overseeing product trials and regulatory inspections
 Keeping up to date with changes in regulatory legislation and guidelines analyzing complicated information, including trial data
 Offering advice about company policies, practices and systems obtaining marketing permission
 Liaising and negotiating with regulatory authorities
 Ensuring that quality standards are met and submissions meet strict deadlines


<Necessary Skill / Experience >
 Thai nationality , Male/Female, age 30-40 years old
 Bachelor’s degree
 At least 5 years working experience in Regulatory Affairs Functions especially in pharmaceutical products
 Have good experience in working with FDA in preparation of documents for the product registration until product marketing approval.
 Understanding of the rules and regulations for Pharmaceutical/Biological products.
 Good command in verbal and written English (to communicate closely with overseas team)
 Computer Literacy (MS Office, MS Excel, etc.)

<Preferable Skill / Experience>
 None

Languages skills
English: Conversational Level
Japanese: None

Workplace Area: BTS Krungthonburi, Bangkok
Working Hour: 9:00-18:00 (Mon-Fri)

About the Benefits
Salary: 50,000–75,000THB

About the company
Products: Producer of anti-retroviral drugs for the treatment of HIV/AIDS
Business Type: Pharmaceuticals

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