Associate Director/Director, Global Regulatory Affairs

8 - 10 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 10/15/17
Pleasanton, CA
8 - 10 years experience
Biotech/Pharma
Salary depends on experience
Posted on 10/15/17

The Associate Director/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 lead Regulatory Submission Teams, design programs for complete and accurate IND/CTA submissions, and ensure that clinical trials are designed to meet regulatory requirements.

 

Responsibilities:

 

  • Create long-term global regulatory strategy by understanding the industry and regulatory landscape combined with business priorities and goals
  • 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 preparation for project documents 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
  • Although this position collaborates extensively with others, there are no direct reports at this time

 

Qualifications:

 

  • PhD or PharmD in life sciences with 6+ years of regulatory affairsexperience is preferable, or BS/MS in life sciences with 8+ years of regulatory affairsexperience
  • Experience with oncology drug development is highly desirable 
  • Extensive submissions experience at the IND and NDA stages, and prefer to manage projects
  • Experience with FDA, other health authority meetings/interactions desirable
  • Documented history of successful interactions with regulatory authorities in North America and Europe
  • Knowledge of the drug development process, drug laws, and global regulations and requirements required
  • Flexibility combined with the ability to prioritize and manage multiple tasks simultaneously is essential
  • Broad background and ability to work across multiple functions
  • Effective oral and written communication skills
  • Strong analytical, problem solving, and presentation skills required
  • Proficiency using Microsoft Office products and electronic systems required
  • Familiarity with project management principles is a plus
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