Regulatory Affairs Manager
7 months ago
Manage all activities related to product commercialization for pharmaceutical products, medical devices and biologics (from import, production, clinical trials, to registration)
- Review and evaluate product documentation, along with coordination for any additional documents, clarifications, samples, etc. as required for GMP certification and product registration
- Identify potential paths to registration, risks, and potential mitigations for technologies under evaluation
- Ensure that all practices comply with the laws, guidelines, regulations and practices in
Thailand
- Provide input and advance notification on potential regulatory and quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations
- Maintain high level regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain
- Manage and coordinate all relevant pharmacovigilance activities for the products according to Thai FDA regulations
- Ensure documentation of the registered products
- Perform all other duties assigned by management
- Maintain excellent working relationship with Thai FDA and governing bodies
- Maintain excellent working relationship with academic institutions, companies, and other entities that Company works with
- Able to discuss with all Thai parties on Company’s behalf
**Qualifications**
- Must be a Thai national
- Bachelor’s Degree in Pharmacy
- Minimum 2years of work experience in RA (New Drugs, Biologics, Medical Devices)
- Good command of English - speak, read, write
- Demonstrated success in key negotiations
- Able to wear multiple hats in an early stage startup
- Takes initiative and is intellectually honest. Will research or consult if does not know or is not certain of the answer, whether about business or about how to navigate through FDA regulations
- Excellent working relationship with Thai FDA is an advantage
- Experience in product registration for biological products or new drugs is an advantage
- Experience in Thai FDA is an advantage
ประเภทของงาน: งานประจำ
เงินเดือน: ฿50,000.00 - ฿75,000.00 ต่อเดือน
ประสบการณ์:
- pharmacist: 2 ปี (ต้องการ)
ภาษา:
- ภาษาอังกฤษ (ต้องการ)
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