position overview
Job Location : China ( 中国 )
Job Type: Permanent Full-time ( remote)
We are searching for a competent Regulatory Affairs Specialist ( Drugs) for our office in China. The successful candidate should have at least 3 years of experience in Regulatory Affairs in China and has interacted and participated in drugs registration with CFDA. The RA specialist will be responsible compiling regulatory submissions and assist RA manager in projects.
RESPONSIBILITIES
- Preparation and writing of documents needed for submission.
- Translate necessary documents
- Submit necessary files and applications for respective HA
- Formatting, Hyperlinking and converting documents to PDF’s
- Research on Chinese regulation and communicating them to GRP.
- Applying knowledge of electronic publishing requirements to ensure compliance with agency submission requirements
- Remaining current with evolving standards for electronic submissions
- Keeping abreast of regulatory procedures and changes.
- Performing quality control checks for submission ready documents.
- Participating in regulatory-clinical cross functional team meetings and project teams.
- Tracking of regulatory projects and submissions.
- Meeting the timelines of regulatory submissions.
- Performing regulatory intelligence and research on different projects.
- Assisting RA manager in the finalization of the regulatory submission.
REQUIRED QUALIFICATIONS
- Requirements include a B.A./B.S. degree in the Life Sciences or a related field, and self-starting ability with excellent written and verbal communication skills.
- At least 2 to 3 years’ experience in preparing regulatory submissions, publishing and in documents management in pharma or biotech industry.
- Proficiency in MS Word, MS Excel, and Adobe Acrobat is essential.
- Experience using electronic submission software is a definite plus, as is proficiency in preparing documents that are compliant with electronic submission standards.
- Familiarity with Microsoft Access and SharePoint is preferred.
- Understanding of the drug development process.
- Working knowledge of industry legislation and best practices
- Document management, or equivalent technical experience.
- Project management.
- Ability to work in a fast-paced environment that is primarily timeline-driven.
- Ability to manipulate large and complex documents required for submissions.
- Attention to detail with the ability to multi-task.
GENERAL REQUIREMENTS:
- Minimum Experience Level: 3-year
- Career Level: Mid-Career
- Minimum English Level: Daily Conversation
- Minimum Mandarin Level: Native
- Minimum Education Level: Bachelor’s Degree
- Visa Status: Permission to work in China required
- Age Limit: No Age limit for applicants
INFORMATION ON GRP
- Company type: International CRO
- Company Headquarters: USA
- Office Locations : China; Shanghai and Beijing ( 上海、北京)