14 Dec

Senior Director Regulatory Affairs Jobs Vacancy at Clovis Oncology Inc

Position
Senior Director Regulatory Affairs
Company
Clovis Oncology Inc
Location
ENG
Opening
14 Dec, 2017 30+ days ago

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:

Job Summary

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.

Job Responsibilities

  • 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.
Qualifications

  • 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.
Education and Experience

  • 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.
Working Conditions

  • Office-based, variable travel, likely up to approximately 20%


Jobs Vacancy Related to Senior Director Regulatory Affairs:

11Dec

Regulatory Affairs Senior Director Jobs Vacancy at Astrazeneca Cambridge. Astrazeneca Cambridge opening great career opportunity and jobs vacancy for Regulatory Affairs Senior Director position. This jobs vacancy will be open for new jobs applicant starting for 11 Dec, 2017. Due to expansion, the Respiratory, Inflammatory and Autoimmune (RIA) team is currently seeking an experienced Regulatory Affairs Senior Director to join a group... ... Continue reading -->


09Dec

Senior Regulatory Affairs Director Jobs Vacancy at Astrazeneca Cambridge. Astrazeneca Cambridge opening great career opportunity and jobs vacancy for Senior Regulatory Affairs Director position. This jobs vacancy will be open for new jobs applicant starting for 09 Dec, 2017. Senior Regulatory Affairs Director. As the Senior Regulatory Affairs Director you will be accountable for leading the development and implementation of the... ... Continue reading -->


29Nov

Regulatory Affairs Senior Director Jobs Vacancy at Astrazeneca . Astrazeneca opening great career opportunity and jobs vacancy for Regulatory Affairs Senior Director position. This jobs vacancy will be open for new jobs applicant starting for 29 Nov, 2017. Regulatory Affairs Senior Director, Oncology. The Regulatory Affairs Senior Director is accountable for leading the development and implementation of the global... ... Continue reading -->


27Sep

Government Affairs Director Jobs Vacancy at Motorola Solutions London. Motorola Solutions London opening great career opportunity and jobs vacancy for Government Affairs Director position. This jobs vacancy will be open for new jobs applicant starting for 27 Sep, 2017. As a Government Affairs Director you will be responsible for:. To be successful as a Government Affairs Director you should be/have:.... ... Continue reading -->


26Oct

Medical Director Senior Jobs Vacancy at Medpace London. Medpace London opening great career opportunity and jobs vacancy for Medical Director Senior position. This jobs vacancy will be open for new jobs applicant starting for 26 Oct, 2017. Your experience to date must have included exposure to clinical trial research, drug development and regulatory affairs, and pharmaceutical industry experience... ... Continue reading -->