Senior Regulatory Affairs Pharmacist
5 days ago
ยา/เภสัชกรรม
วันนี้
- คุณสมบัติพื้นฐาน
- งานตามสัญญาจ้าง รายเดือน/รายปี- 3 - 8 ปี- กทม. (ปทุมวัน)- ปริญญาตรีหรือสูงกว่า- 40,000 - 80,000 บาท/เดือน- หน้าที่และความรับผิดชอบ
**PRIMARY FUNCTION**
- For Thailand and Vietnam:
- Distributor management in Thailand and Vietnam
- Regulatory activities, including new product registrations, renewal registration, variations and maintenance of registered pharmaceutical products and other healthcare products as assigned in the future complying with policies and procedures to meet statutory, quality and business requirements.
- Provide support to commercial team from regulatory perspectives
**CORE JOB RESPONSIBILITIES**
- Regulatory:
- Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
- Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution and sale & marketing of products.
- Facilitate communication between Area Regulatory leads and the distributors in Thailand and Vietnam regulatory departments.
- Product registration and approval:
- Develop registration strategies, prioritizing assignments; implement regulatory plan and coordinate multiple projects and activities in accordance with strategic company objectives, annual plan and targets.
- Review, analyze and coordinate data for new product submissions, line extensions according to priorities and responses to deficiency letters. Ensure that the content comply with government regulations prior to submission to Regulatory Authority.
- Through the distributor, maintain an awareness of country’s regulatory legislation and assesses its impact on business.
- Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
- Product maintenance:
- Up to date of product registration, variation, line extension and other related law & regulations knowledge.
- Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
- Update and maintain regulatory databases.
- Ensure timely updates of related regulatory systems and compliance to SOPs
- Ensure effective implementation and maintenance of processes and systems
- Manage labelling changes, artwork development and artwork approval of packaging material components
- Plan the regulatory activities and work collaboratively with supply chain to ensure timely maintenance of product labels to ensure compliance to requirements, and continuity in supply.
- Support marketing activities:
- Provide regulatory input and support for marketing plans, product launches and other cross
- functional activities.- Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.
คุณสมบัติ
- Bachelor’s degree in Pharmaceutical Science or Pharmacy
- At least 3 years of work experience in regulatory affairs for Thailand
- Experience in regulatory submissions in other ASEAN countries will be added advantage.
- Strong communication skills - both oral and written and proficiency in English and Thai.
- Strong interpersonal skills
- Understands business needs and impact of regulatory issues
- Ability to work independently and proactively.
- Employment Type: Contract 1 year (renewable) with benefits
- Company: International FMCG Pharmaceutical Company
- Location: near BTS Ploenchit, Pathumwan, Bangkok
ดูคุณสมบัติเพิ่มเติม
- สวัสดิการ
- Annual leave
- Bonus 1 times/year
- Life and Health Insurance
- Life insurance
- Medical insurance
- ทำงานสัปดาห์ละ 5 วัน
- ประกันสังคม
- ประกันสุขภาพ
- ประกันอุบัติเหตุ
- เบี้ยขยัน, ค่าตอบแทนพิเศษ
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