Regulatory Specialist II
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Job Description
List 3-5 hard requirements for the role: Responsible for regulatory activities, including product registrations, impact assessment, etc.
Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
Plan and execute the given tasks proactively in a timely manner.
Report the status to a manager weekly. Keep the training records up to date to do the tasks.
List any preferred requirements that would stand out on a resume: understand technical sections (risk management, product change control, biological evaluation)
Years of experience required: 5+
Required education level/certifications: BS, MS Daily tasks/duties and department interactions: prep submissions, regulatory strategy, review change control, other assigned tasks. Interacting with QA, Labeling, Engineer, PMO. Etc.
Description of work environment/department: Assigned Desk, quiet area but dynamic work,
Occasional night calls (after 5PM) with Affiliates.
Preferred interview method (one step or two step/phone or video conference): video interviews- two step interviews
