Director of Global Regulatory Strategy
1 day ago
We are a leading healthcare company headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
The Director of Global Regulatory Strategy, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable for establishing the local regulatory strategy and plan for assigned product(s) in region/country, ensuring local plan aligns to the global regulatory strategy (i.e. RSD), and including local regulations and region/country business needs.
- To provide regional regulatory expertise in delivering high-quality and efficient regulatory submissions, approvals, and local labeling for their assigned product(s).
- May perform regulatory evaluations of external business opportunities, as requested by management, and may effectively manage alliance/CRO relationships in regulatory area.
- Providing Regulatory Expertise for Assigned Program/Product(s) in Region/Country
- Region/country input and review of global strategic plans and global/regional submission plan and documents.
- Contribute during key governance committees on regional regulatory strategy decisions, if requested.
- Ensure approval and delivery of content for local regulatory submissions, engaging cross-functional partners in contributing to development of submission content.
- Lead development of local/regional labeling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones.
- Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country.
- Ensure compliance with all applicable regulations and internal quality systems.
- Own all regulatory activities in support of assigned marketed product(s) in the region/country.
The estimated salary for this position is $120,000 - $180,000 per year, depending on experience and qualifications. This is a full-time position based in Indianapolis, Indiana or remote location within EMEA region.
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