Job summary
Job category | Professional (Consulting / Finance / Real Estate / Professional Services)/Professional Services (Health Care / Welfare / Education / Instruction) |
---|---|
Industry | Other/ |
Employment type | Uncategorized |
Position level | Other |
Number of openings | 1 |
Desired entry time | - |
Required language skill |
English (Conversation) |
Foreign language competence | - |
Working hours | Others |
Welfares / Leave systems |
Work details
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
About interview
Liaison
Regulatory Affairs Manager (Pharmaceutical Products) / ผู้จัดการด้านการขึ้นทะเบียนผลิตภัณฑ์ยา
RGF HR Agent
50000 〜 75000 THB