Senior Director Regulatory Affairs Jobs Vacancy at Clovis Oncology Inc
Clovis Oncology Inc urgently required following position for Senior Director Regulatory Affairs. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.
Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.
Senior Director Regulatory Affairs Jobs Vacancy at Clovis Oncology Inc Jobs Details:
The Senior Director of Regulatory Affairs must have a broad understanding of the global regulatory requirements including EU and other international markets and be able to prepare and manage global submissions. The Senior Director must be able to develop, communicate and implement regulatory strategy. The Senior Director develops objectives, schedules, and performance metrics and ensures that all requirements are met and is required to manage direct report regulatory team members.
- Represent Regulatory Affairs on global project teams, subteams and in joint alliances as required. Representation may be ad hoc or permanent depending on the stage of development.
- Direct all aspects of regulatory support and strategy for EU and international for the global project team on the designated product(s).
- Ensure the project team objectives and timelines are supported by well defined and agreed regulatory deliverables
- Interface with management to ensure consistency of regulatory strategy with corporate goals.
- Responsible for being regulatory contact for assigned projects.
- Lead, facilitate and coordinate regulatory meetings for the assigned projects.
- Lead, facilitate and manage within function regulatory team meetings.
- Ensure regulatory objectives are met.
- 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 or others within the regulatory team and management.
- Provide expertise in the interpretation of regulations and guidance relating to product development.
- Work with the RA team, to guide the preparation and submissions to regulatory authorities
- Prepare, review and approve documentation used in regulatory submissions.
- Deputize for the SVP Regulatory Affairs
- Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
- Coordinate with the US based Regulatory Affairs group for global regulatory strategy and submissions.
- Coordinate and manage consultants and contractors as required.
- Day to day oversight of EU/International Regulatory group.
- Goal set, manage, train, motivate and direct regulatory staff reporting to the Senior Director.
- Broad understanding of drug development and oncology in particular.
- Competency in regulatory requirements is essential. Global experience a plus.
- Excellent verbal and written skills.
- Flexible mindset and ability to multitask.
- Minimum of BSc in a relevant scientific discipline, advanced degree preferred.
- At least 10 years of regulatory affairs experience and a minimum of 15 years total pharmaceutical industry experience.
- Experience of contributing and serving on project teams.
- Office-based, variable travel, likely up to approximately 20%