Job Detail
RA/QA/PV Pharmacist (30K–50K) (SDG-57707)
<Job Responsibilities>
1. Regulatory Affairs
- Keeping up to date with Thailand national legislations and regulations impacting the registration, marketing, promotion and distribution of pharmaceutical products
- Communicating and updating Regional RA on any new regulatory requirements in Thailand
- Communicating and collaborating with Regional RA and business partners on regulatory issues, including highlighting of potential regulatory problems or supply chain disruptions
- Conducting regulatory assessment and developing regulatory submission
- strategies for new and current products in Thailand
- Submitting necessary applications to Thailand FDA
- Interacting and maintaining good professional relationship with Thailand FDA officers
- Performing local adaption of regulatory dossiers into eCTD/ACTD format as required by Thailand FDA
- Translating and reviewing texts/artworks required for labelling and ensuring that local labelling requirements are met
- Obtain and/or maintain the necessary regulatory licenses, i.e. Modern Drug Importation and Wholesaling License, Product importation license, etc. as the Responsible Pharmacist/Managing Pharmacist of company in Thailand
- Maintaining a high standard for the archival and retention of regulatory documents
- Read, be aware and follow all RA SOPs and work instructions as applicable
2. Pharmacovigilance
- Establish a PV system in company in compliance with Thailand national legislations, Regional’s PV and International PV requirements, as appropriate
- Conduct employee PV training, i.e. reporting of individual case safety reports for company’s products
- Communicating and updating Regional PV and affiliates on any new PV requirements in Thailand
- Interacting with internal and external stakeholders (i.e. distributors /manufacturers) on PV matters
3. Quality Assurance
- Communicating with regional and business partners on quality issues pertaining to Good Distribution Practices and Good Manufacturing Practices
- QA Liaison with applicable manufacturing/packaging sites
- Conducting batch release / providing quality disposition for the distribution of products
- Participating in regional quality assurance activities, i.e. shipping validation, as required
- Assisting with importation custom clearance activities as the responsible pharmacist for company
4. Others
- Drafting, reviewing and ensuring adherence to RA, QA and PV related agreements
- Drafting, reviewing and implementing necessary RA, QA and PV SOPs to ensure regulatory compliance or improving work processes
- Potential engagement in Regional / International RA, QA and PV projects
- Other duties assigned
<Necessary Skill / Experience >
- Thai nationality, Male/Female 25-40 years old
- Bachelor’s degree of Pharmacy with valid 1st Class Pharmacist Practicing License in Thailand
- At least 3-year experience in regulatory affairs for pharmaceutical products in Thailand with some experience in submitting new chemical entities or new biological products in other regions outside Thailand
- At least 2-year experience in handling Quality Assurance
- Familiar with Pharmacovigilance activities for pharmaceutical companies
- Conversational high level of English
- Experience in working with cross-functional teams with a good understanding of commercial activities in a pharmaceutical industry
- Good understanding of Thailand regulatory requirements
- Familiar with regional (i.e. ASEAN) and global regulatory requirements and landscape
- Good understanding of GMP, GDP and GVP requirements
- IT-proficiency (i.e. Microsoft Office applications)
Soft skills
- Adaptable, Independent, Team player, Resourceful
<Preferable Skill / Experience>
- None
Languages skills
English: Conversational Level
Japanese: None
Workplace Area: BTS Ploenchit, Bangkok
Working Hour: 8:30-17:30(Monday-Friday)
About the Benefits
Salary: 30,000–50,000THB
About the company
Products: Promotion of ethical pharmaceutical products
Business Type: Pharmaceuticals
