Regulatory Affairs Opportunities at Clovis Oncology
June 7, 2018
San Francisco, Colorado
To be determined based on expe
Full Time - Experienced
Pharmaceuticals, Quality/Risk Management
At Clovis Oncology, we are committed to advancing the treatment of cancer to better serve patients in need, and are seeking others who share our vision. We are a small, growing, international company, and our team is committed to realizing the potential of precision medicine in oncology – delivering the right drug to the right patient at the right time.
The Regulatory Affairs development is built around global project teams, each team comprising members from key functions. These teams work on projects ranging from the pre-clinical stage to phase IV programs. Clovis Oncology operates a matrix organization, and employees must be able to work effectively with functional peers (e.g. Pharmacovigilance, Biostatistics, CMC etc) within the project sub-team environment. The Regulatory Affairs function is high profile within the organization and is very much “hands on”.
We are expanding our US Regulatory Affairs team, and we have a number of opportunities, including:
Senior Manager, Regulatory Project Management
The Senior Manager, Regulatory Project Management (RPM) is responsible for the planning and successful execution of global regulatory projects and submissions. The RPM will work with all staff within Clovis Global Regulatory Affairs, ranging from Specialist to SVP levels, covering regulatory strategy, filings, clinical trials and operations. The RPM will ensure that regulatory deliverables are aligned and incorporated into Clovis’ global Project Team plans throughout all phases of Product Development.
Senior Director, Regulatory Affairs
The Senior Director of US Regulatory Affairs must have a broad understanding and experience of US FDA requirements and be able to prepare and manage all aspects of US submissions. The Senior Director must be able to develop, communicate and implement regulatory strategy. The Senior Director develops objectives, schedules, and performance metrics and ensure that all regulatory requirements are met and is required to directly line manage the US based regulatory team members.
Associate Director, Regulatory Affairs
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.
Manager, Regulatory Affairs
In conjunction with other members of the Regulatory Affairs function, the RA Manager will be responsible for preparing and maintaining regulatory submissions in line with FDA, EMA, and ICH requirements and guidelines and company policies and procedures. Focus will be on US, but may also have responsibilities in territories including Canada, EU, Japan, and Rest of World. The RA Manager is expected, with assistance, to provide regulatory expertise and input across multiple aspects of the development programs.
We are a biopharmaceutical company focused on acquiring, developing and commercializing cancer treatments in the United States, Europe and other international markets. Our development programs are targeted at specific subsets of cancer, combining precision medicine with companion diagnostics to direct therapeutics to those patients most likely to benefit from them.