Senior Regulatory Affairs Program Manager
New
United StatesFull-TimeManager
Salary154,400 - 231,600 USD per year
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Job Details
- Experience
- Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
- Required Skills
- Project ManagementCompliance
Requirements
- Baccalaureate degree.
- Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
- Lead or compile all materials required in submissions, license renewals, and annual registrations.
- Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitor and improve tracking/control systems.
- Keep abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommend strategies for the earliest possible approvals of clinical trial applications.
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