Job Description
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
Job Requirement
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