台新藥股份有限公司
Regulatory Affairs Associate/Supervisor
10/1 Updated
Array
Full-time
Mid to Senior Level
English Required
6 ~ 10 applicants

Salary & Location

Salary negotiable
(Regular monthly salary of NT$40,000 or above)
桃園市蘆竹區

Required

Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
1年以上

Job Description

【Position Summary】
Formosa Pharmaceuticals is a clinical biopharmaceutical company operating in the areas of ophthalmology and oncology. We seek a Regulatory Affairs to join our team. The successful candidate will work closely with the RA head to manage the product registrations for global markets. Clear, concise, and effective communication skills in English speaking and writing are essential. Title and salary are commensurate to the level of experience.
【Job Responsibility】
- Compile the registration dossier for new IND/NDA/BLA registration.
- Support the regional partners in life-cycle management of approved drug products, such as post-approval change reporting and annual reporting.
- Communicate with local authority (TFDA) to resolve regulatory issues.
- Apply for import permit, export permit, export license, etc.
- Maintain and renew of export license, pharmaceuticals distribution license and GDP license.
- Complete tasks assigned by the department head, including cross-departmental function and collaboration.
【Qualifications】
- Bachelor’s Degree in a science-related field with 1+ years’ experience in a pharmaceutical setting.
- Strong understanding of ICH M4Q “The Quality section of the Common Technical Document”.
- Excellent interpersonal and communication skills, including written and spoken English and Chinese, in an individual or team setting.
- Proficient with Microsoft Office, including Microsoft Word skills such as document formatting, creating tables, headers and bookmarks, table of contents, etc.
- Stay current with local and international regulations and guidelines.
- Experience with eCTD software is a plus.
【Required application material】
- CV with detailed description of RA experience
- References with contact info is appreciated
Number of Openings
1~1人
Educational Requirements
專科以上
Work Schedule
日班
Leave Policy
週休二日

Job Skills

Familiarity with Pharmaceutical Administration and Regulations
熟悉藥事行政與法規
Job Category
Commercial Registration Staff
Other Legal Professionals
Pharmaceutical Research and Development Staff
台北市松山區
生化科技研發業
台新藥(股票代號:6838)成立於2010年,為一家生物製藥公司,專注於臨床前與臨床階段之眼科、腫瘤科和抗感染用藥等治療領域的藥物開發,透過創新研發和多向風險分攤等開發策略來推動新藥上市,途徑包括505(b)(2)、生物相似藥以及全新藥(新成分)。 2017年8月,台新藥收購位於日本船橋的Activus Pharma,取得擁有廣大應用範圍的Activus Pure Nanoparticle Technology(APNT)平台技術及兩項臨床前期資產。藉由台新藥專有的APNT 奈米製劑平台,可達成提高候選藥物PK(藥物動力學)以及BA(生體可用率)的需要,因而在眼科疾病領域獲得了領導地位。在這些眼科的候選藥物中,APP13007 (適應症為眼科術後導致的發炎與疼痛)已取得美國藥證,並已完成多國授權案,即將邁入供貨全球的新里程碑。
6 ~ 10 applicants