ประสบการณ์:

1 ปีขึ้นไป

ทักษะ:

English, Thai

ประเภทงาน:

งานประจำ

• Manage all activities related to product registration for pharmaceutical products, OTC, Herbal products and other categories.
• Review and evaluate the product documentation along with coordination for any additional documents, clarifications, samples, etc. as required for product registration.
• Make sure that all submissions/approvals comply with the laws, guidelines, regulations and practices in Thailand.
• Communicate the approved information &/or any changes to the concerned departments within/outside the company.
• Take initiative in local government affairs activities by cultivating close relationships with government agencies in order to influence and respond proactively to the development of laws and regulations governing product registrations.
• Provide input and advance notification on potential regulatory & quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations.
• Maintain a high level of regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain.
• Manage and coordinate all Pharmacovigilance activities for the products according to Thai FDA regulations.
• Ensure documentation of the registered products.
• Develop and coach team members to meet goals and objectives set.
• Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and on quality.
• Bachelor's Degree or Master's Degree in Pharmacy.
• Minimum 5 years of management experience in the pharmaceutical industry or drug regulatory affairs.
• Experience in product registration for pharmaceutical products, chemical & biologics for ethical, OTC, and other products is an advantage.
• A pharmacist license is necessary.
• Good networking skills and result-oriented.
• Professional use of MS Office.
• Fluency in English language - speaking, reading, writing.
• Ability to multitask and deliver on multiple projects.
• Excellent working relationship with Thai FDA and demonstrated success in key negotiations.
• Open & interested in working in Bangna, Bangkok.
• Skill & Knowledge.
• The ideal candidate must possess excellent knowledge and understanding of regulatory compliance and strong know-how of local regulatory requirements for product registration. The role requires the ability to work effectively under pressure, as well as strong skills in coaching and mentoring, management and leadership, and solid analytical and problem-solving capabilities to resolve regulatory challenges.
• Salary increment.
• Annual leave.
• Yearly bonus (paid twice a year).
• Provident fund.
• Life insurance.
• Medical insurance/reimbursement (IPD & OPD).
• Annual health check-up.
• Uniform.
• Annual Party.
• Good Health by Yourself activities.
• Shuttle bus/van.
• Special Price Products.
• etc.
• If you are eager to make the most of your opportunity, please send your resume.
• via APPLY NOW.
• For further information, please call.
• 02---- ---- ext. -019.
• (Khun Thachacharn-Time).