Overview

The Senior Director, Global Regulatory Affairs will support oncology development programs, provide regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions, and regulatory processes.  This individual will represent Regulatory Affairs on Project Teams, lead Regulatory Submission Teams, create timelines for complete and accurate IND/CTA and NDA/MAA submissions, ensure that clinical trials are designed to meet regulatory requirements, and guide programs to registration submissions.

Responsibilities:

  • Plan content and timelines of regulatory submissions to ensure alignment with agreed strategies
  • Proactively identify regulatory issues and provide solutions to keep assigned programs on time, while maintaining the highest quality
  • Lead efforts for coordinating content and publishing documents for original INDs, Clinical Trial Applications and NDAs, and their associated maintenance
  • Lead multidisciplinary efforts to produce an IND every year
  • Work with department management on plans for NDA/MAA submissions and lead their preparation
  • Take the lead role in Astex preparations for Regulatory Agency meetings
  • Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority meetings
  • Work with offshore regulatory organizations to prepare applications, respond to queries, and maintain our clinical activities outside of the United States
  • Maintain knowledge of the current regulatory environment, and interpret and communicate relevant issues to your colleagues
  • Assure compliance with regulatory standards and guidance documents
  • Prepare, submit, track, index, and archive electronic submissions
  • Provide Regulatory guidance to our Manufacturing, Discovery and Development teams
  • Liaise with Medical Writing for coordinating and publishing submission documents
  • May include management of department staff

Qualifications:

  • PhD or PharmD in life sciences with 8+ years of regulatory affairs experience is preferable, or BS/MS in life sciences with 10+ years of regulatory affairs experience
  • Experience at the development (IND/CTA) and registration (NDA/MAA) stage
  • Experience with regulatory health authority interactions in North America and Europe
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously
  • Preference to manage projects
  • Effective oral and written communication skills
  • Broad background and ability to work and influence across multiple functions
  • Experience with oncology drug development desirable
  • Knowledge of the drug development process, drug laws, and global regulations and requirements required
  • Strong analytical skills, problem solving ability and presentation skills required
  • Proficiency using Microsoft Office products and electronic systems required; experience with documentation systems and publishing tools a plus
  • Familiarity with project management principles is a plus

To apply for this job please visit chp.tbe.taleo.net.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.