Deciphera Pharmaceuticals Inc.

Job Title: Senior Director/Director Regulatory Affairs

Job Number: 21764

Location: Waltham, MA

Job Description

The Director/Senior Director will manage a group of highly motivated, top-notch regulatory professionals and will be a key player in shaping cohesive regulatory strategies across the development pipeline.
Key Responsibilities:

  • Working with the regulatory leads to develop regulatory strategies for multiple oncology development programs (from FIH through post-marketing stage)
  • Address complex issues by providing solid regulatory solutions and guidance to the regulatory leads and, as needed, to the cross-functional teams and senior management
  • Monitor global regulatory changes that may impact asset development
  • Provide tactical support and operational expertise when “hands on” support is needed
  • Counsel and advise Vice President of Regulatory Affairs & Quality on the status of Regulatory Affairs strategies and tactics, procedures and practices
  • Ensure compliance of regulatory strategies and submissions
  • Assess project plans and timelines; manage staff effectively to ensure all projects are appropriately prioritized and key goals are met on time
  • Contribute to the continuous improvement of existing department processes and create new processes to support the evolution of the company
  • Manage staff performance and plays a key role in developing career growth opportunities for staff

Minimum Qualifications

  • Ph.D. and 10+ years of work experience in pharmaceutical regulatory affairs, or • B.S/M.S. and 12+ years of work experience in pharmaceutical regulatory affairs
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU
  • Must have experience filing INDs and NDAs/BLAs

Preferred Qualifications:

  • Capable of strategic thinking and proposing innovative solutions to regulatory problems
  • Demonstrates excellent verbal and written communication skills with ability to positively impact and influence peers, direct reports, and supervisor

Responsibilities

Required Skills

 

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