Offer summary
Qualifications:
In-depth device regulatory experience, Strong knowledge of drug development processes.Key responsabilities:
- Lead global regulatory strategy implementation
- Manage submissions and interface with stakeholders
Lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the primary interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs). Positively contributes to the global regulatory strategy for clinical and commercial therapeutic programs, Facilitate identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of IVD/CDx global submissions. Management or leadership of junior regulatory personnel. Manages contractual and budgetary responsibilities with best business practices. Remains current with evolving regulation and guidance for integrated review of guidance to develop strategies.
Primary Responsibilities Include:
Desired Education and Skills:
This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $180,000 - $225,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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