Category
Legal
Publish Date
Wednesday 13-10-2021
Country
Egypt
Gender
any
Years Of Experience
3 - 5 Years
Salary
Negotiable
A joint venture company located on the 6th of October is hiring a Food Registration Specialist
Job Description:
- Prepare and file regulatory submissions (AND As, amendments, supplements, annual reports, 505(b)(2) and 505(b)(1) files)
- Perform assessments of new or revised products
- Manage complaint documentation(including investigation and closure)
- Respond to inquiries from regulatory bodies, including the FDA
- Perform or facilitate audits to ensure compliance
- Collaborate with project team members to obtain documentation and establish timelines
- Improve internal processes to reduce risk
Qualifications:
- A bachelor’s degree in life sciences or a technical field (required)
- A master’s degree in regulatory affairs, a plus
- RA certification in the U.S. or EU (preferred)
- Regulatory experience in the industry (5-10 years, preferred)
- Up-to-date knowledge of international, federal, and state guidelines
- Sound judgment
- Organizational and communication skills
- Attention to detail
