Opportunity Description
Responsibilities:
- Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
- The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
- Document regulatory strategies for product submissions.
- Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing ...
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