Director of Regulatory Affairs – International

Employer
Location
International
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
MS
Career Fair Category
Career Fair

Director of Regulatory Affairs – International   

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Responsibilities

  • Develop and implement innovative regulatory strategies in support of global development, registration and life-cycle management of oncology programs
  • Advise teams and management on the impact of regulatory climate and changing regulations pertaining to research and development programs and commercial operations
  • Lead TESARO interactions with European Medicines Agency  and International governmental agencies on assigned products
  • Develop and implement strategies for the most efficient, timely submission and approval of regulatory filings from clinical trial applications through Phase 4. 
  • Drive decision-making in the cross-functional teams with respect to regulatory issues.
  • Provide regulatory sign off on packaging material in order to support the International product launches
  • Provide regulatory sign off on promotional and educational material in order to support the International product launches
  • Develop regulatory processes, procedures and infrastructure to support company growth

Requirements

  • Masters of Science degree in life or health sciences or other related healthcare related discipline
  • 9+ years pharmaceutical industry experience in regulatory affairs
  • Working knowledge of  small molecule and biologics medicinal products  International guidelines and regulations
  • Marketing Authorization Application (MAA) or late-stage development leadership experience
  • Working experience with Centralized Procedure is required; international experience a plus
  • Direct experience with scientific advices procedures, as well as pediatric development plans and orphan drug procedures
  • Experience required in oncology clinical and non-clinical product development

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, PLEASE CONTACT US AT
careers2@tesarobio.com