CMC Regulatory Affairs Director
7 hours ago
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.
- 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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