Job Description
<Job Responsibilities> • *This position supports and execute the below tasks during the current staff takes maternity leaves. • *The contract time will be Nov 2022 - May 2023 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 • Report and communicate about the above issues with Japanese Headquarter or Singapore Regional Headquarter in English • Other tasks assigned <Necessary Skills / Experiences> - Thai nationality, Male, Female, 22-45 years old - Bachelor’s Degree of Pharmacy - Fresh graduate welcomed - At least 1 year experience in RA or QA or PV in medical company - Conversational high level of English <Preferable Skills / Experiences> - Experience in communicating with government - Having Pharmacist License Languages skills English: Conversational Level Japanese: None Workplace Area: BTS Ploenchit, Bangkok Working Hour: 8:00-17:00 (Mon-Fri (Sat: none)) About the Benefits Salary: 25,000–40,000THB About the company Product & Service: Psychiatric products Business Type: Pharmaceuticals