FDA Consultant
The company is a consulting firm that offers FDA related consulting services to help clients achieve success in business expansion in the U.S.
You will be responsible for providing guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements.
Salary
$ 50K-90K / year
Job Location
Gardena, CA
Type of employment
Full time
Language
English Japanese
Work hours
9:00 AM - 6:00 PM
Remote Work
○（Temporarily due to COVID-19）
Industry
Management Consulting
Visa Sponsor
×
Posted
2 years ago
Job ID
#1222
Benefits
Competitive employee benefits package
(Insurance, Sick Leave, Paid Vacation, etc.)
Responsibilities and Duties
- Work with clients to develop regulatory strategies and plans for FDA.
- Conduct intense, accurate regulations and market research on various industries (FDA, EPA, USDA, state, city, food, etc.)
- Work with an internal and external project team and client to meet regulatory deadlines, respond to FDA issues and assure the integrity of submissions.
- Provide advice on drug development strategies.
- Act as a liaison between clients and regulatory agencies including translation to and from Japanese and English.
- Other duties as requested or as responsibilities dictate
Qualifications
- Native level or close Native level fluency in Japanese verbally and in writing
- Bachelor degrees in a science field（ex: Biology, Chemistry, Biochemistry, Engineering, Medical, Pharmaceutical, etc.) is s must. Master’s or Ph.D.'s preferred.
- Demonstrated knowledge of FDA requirements.
- Ability to multitask, establish priorities, meet deadlines, and make sound decisions in a fast-paced environment.
- Working experience in related fields such as medical, pharmaceutical or food industry.
- Possess a genuine willingness to learn, be intuitive and resourceful and be coachable.
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