Director, Regulatory Strategy – Contract
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Job Description
Director of Regulatory Strategy at Vertex responsible for global/regional regulatory strategy development. Leading regulatory submission documents and Health Authority communications oversight.
Responsibilities:
- Lead the development of regulatory strategy for assigned projects/regions in development
- Shape the regulatory strategy for regulatory submission documents and Health Authority communications
- Manage project plans and timelines to ensure all projects are appropriately prioritized and key goals are met on time
- Provide regulatory leadership to the GRA functional team(s) or projects with moderate resource requirements or complexity
Requirements:
- Bachelor's degree in Biology, Chemistry, or other related discipline
- 10 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience
- Experience with market product, labeling, new drug development and working with the FDA required
- Advanced technical skill in regulatory affairs science including knowledge of regulatory frameworks and external environments.
- Proficient knowledge of the research and development, preclinical and clinical requirements related to drug development registration, and maintenance of human pharmaceuticals.
Benefits:
- compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
- Eligible for overtime pay in accordance with federal and state requirements.
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