Senior Specialist, CMC Regulatory Affairs

The Sr. CMC Regulatory Affairs Specialist performs regulatory assessment of changes. Interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission form process. A typical day might include the following:

• Reviews regulatory submissions to ensure all aspects of global regulatory and CMC compliance (beyond GMP compliance) are met and fully support clinical supply
• Collaborates cross-functionally to support the submission strategies and impacts on supply and regulatory release processes
• Support the regulatory submission forms to support regulatory release and QP certification.
• Foster strong communication and working relationships between IOPS and Global Development
• Keeps management and all stakeholders informed of assessments, overall strategy, and project status
• Works within the procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
  
  History of building and maintaining positive relationships both internally and externally.
• Strong ability to communicate at all levels with clarity and precision.
• Open and receptive to change while looking for opportunities to continuously improve processes.
• Strong understanding of quality principles in a regulated manufacturing environment helpful.
To be considered for this opportunity, you must have at minimum a Bachelor's degree in a relevant technical, scientific discipline with a 4+ years pharmaceutical/biotech industry experience, including a minimum of 3+ years of relevant CMC experience.