【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