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Clovis Oncology, Inc. Associate Director, Regulatory Affairs in Boulder, Colorado

Job Summary

The Associate Director of US Regulatory Affairs must be able to assess the project from a regulatory standpoint using a broad understanding of the FDA requirements and be able to prepare US submissions. The Associate Director must be able to develop and implement the regulatory strategy. This employee will be a member of the project team and also the liaison with FDA as well as business partners. The Associate Director ensures budgets, schedules and performance requirements are met.

Job Responsibilities • Represent Regulatory Affairs on global project teams, subteams and in joint alliances as required. Direct all aspects of regulatory support and strategy for the global project team on the designated product(s). • Lead, facilitate and coordinate regulatory meetings for the assigned project.
• Responsible for being primary FDA contact for assigned project. • Initiate and update regulatory strategic plans for the projects and coordinate with the project leader for incorporation into a product development plan. Assess pros, cons and risks of the various strategic options and communicate to the project team and management. • Prepare and submit all the required submissions to FDA in support of clinical trials and marketing applications. Review and approve all documents used in regulatory submissions (including protocols and reports). • Ensure the project team objectives and timelines are supported by regulatory deliverables. • Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas. • Provide expertise in the interpretation of regulations and guidance relating to product development. • Coordinate with EU Regulatory Affairs group for global regulatory strategy and submissions. • Coordinate with consultants and contractors as required.

Qualifications

• Broad understanding of drug development and oncology in particular • Competency in FDA regulatory requirements is essential. Global experience is a plus • Excellent verbal and written skills • Flexible mindset and ability to multitask

Education and Experience

• Minimum of BS in a relevant scientific discipline, advanced degree, or RACC certification preferred • At least 6 years US regulatory affairs experience and at least 10 years total pharmaceutical industry experience. • Experience of serving on a project team • Experience with diagnostic tests is desirable

Working Conditions

• Office-based, up to approximately 10% travel

Qualifications

• Broad understanding of drug development and oncology in particular • Competency in FDA regulatory requirements is essential. Global experience is a plus • Excellent verbal and written skills • Flexible mindset and ability to multitask

Education and Experience

• Minimum of BS in a relevant scientific discipline, advanced degree, or RACC certification preferred • At least 6 years US regulatory affairs experience and at least 10 years total pharmaceutical industry experience. • Experience of serving on a project team • Experience with diagnostic tests is desirable

Working Conditions

• Office-based, up to approximately 10% travel

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