What are the responsibilities and job description for the Regulatory Affairs CMC position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- leading / coordinating execution of (CMC) regulatory filing strategy and managing or supporting regulatory processes to achieve timely approval.
- preparing high quality CMC regulatory documents or packages in accordance with company standards and procedures, ensuring thoroughness, accuracy, and timeliness.
- building strong collaboration with internal stakeholders, including Regulatory Affairs, Quality Assurance, Technical Operations and Global Supply Chain; providing functional expertise to matrix / cross-functional teams.
- maintaining current knowledge of regulatory intelligence and processes that may impact regulatory-CMC planning; and keeping abreast of changes in the regulatory environment to better inform stage-specific CMC requirements for clinical studies.
Requirements :
