CMC Regulatory Affairs Director

7 hours ago

San Diego, California, United States Gossamer Bio Full time
Job Summary

The Director/Senior Director, Regulatory Affairs will lead the development and execution of innovative CMC regulatory strategies to support the global development and commercialization of a drug/device combination product. This role requires dynamic leadership and direction to multi-disciplined project teams, working collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner.

Key Responsibilities
  • Develop and execute CMC regulatory strategies to support global development and commercialization of a drug/device combination product.
  • Lead cross-functional project teams to achieve project milestones and goals, including regulatory strategy development.
  • Identify and assess regulatory risks and critical-path activities associated with CMC development programs and develop strategies to mitigate risks.
  • Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs.
  • Evaluate proposed CMC changes for global impact and provide sound regulatory strategies to support compliant change implementation.
  • Lead global CMC regulatory submission development, responsible for planning, coordinating, and developing high-quality, compliant, and timely CMC (Quality) regulatory submissions.
  • Serve as the primary interface for FDA on assigned projects.
  • Prepare and lead teams through successful regulatory meetings and interactions.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidances, and current industry practice as it relates to pharmaceutical development and quality.
  • Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
  • Participate in Business Development efforts, as assigned.
Requirements
  • Bachelor's degree in scientific discipline; advanced scientific degree preferred with 10 years pharmaceutical industry experience, including 5-7 years in CMC Regulatory Affairs.
  • Good understanding and knowledge of small molecule manufacturing and analytical methods is desired.
  • Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
  • Knowledge of global regulatory regulations and guidances as they relate to the overall global regulatory strategy.
  • Inter-dependent partnering skills, team-oriented, and ability to influence outcomes are necessary skills in the environment.
  • Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail.
  • Domestic and occasional International travel may be necessary.
  • This position can be based remotely within the United States or Hybrid from our Dublin, Ireland office.

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