Regulatory Affairs Specialist - Irvine, CA
Job Description :
The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.
Key Responsibilities :
Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates;
track timelines and document milestone achievements, participate in developing regulatory strategy, prioritize submissions with operating plans as well as ensuring alignment with KOD in countries (e.
g., OUS, the globe minus US, EU, Canada ).
Participate in providing guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals.
Participate in representing the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and / or reporting to management.
Participate in providing guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content?
and guidance on process improvement projects, based on prior experience and responses from affiliates.
Education and Experience :
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
5-7 years of experience required
Required candidates who can speak Japanese.
Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE / MBE / SBE / SDB firm accredited by WBENC, NMSDC, and SBA.
Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives.
At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements;
they are about matching your skills and aspirations with the perfect fit.
To learn more about us, please visit our website www. trinus.com
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