The Fountain Group are a national staffing firm and are currently seeking a Director, Global Regulatory Affairs Lead for a prominent Pharmaceutical client of ours.
This position is a Remote Role. Details for the position are as follows :
Job Description :
- Pay : 100.00-157.00 / hr.
- Length of Assignment : 1 year assignment with potential for extension or conversion.
- 100 percent remote role. EST / CST / MST based candidates only as there are frequent 7AM EST calls with global stakeholders.
- Manage, direct, and drive the strategy for all Regulatory activities associated with the registration and support of new and approved drug products.
- Seek and incorporate regional and functional RA strategy into a global strategy.
- Ensure that US / EU / CN / JP and / or global registration strategies are clearly defined in RA strategic plans.
- Ensure aligned global regulatory strategy is endorsed by GPT and other governance bodies.
- Ensure that registration strategies follow the direction of the therapeutic area and align with corporate goals.
- Be accountable to the Global Head of RA, and Global Regulatory Strategy Committee (G-RSC) for the development of global regulatory strategies.
- Serve as the primary point of contact with Alliance Partners Joint-RA teams and Joint-GPT as applicable, ensuring coordination / alignment to global regulatory strategy.
- Manage and be accountable for the overall project strategy and global plan for a submission. Supervise the identification and compilation of required documentation for global submissions and prioritize workflow, as necessary.
Gather input from Regional Strategists on regional requirement.
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