The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs
Job Summary
The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs.
Assists in ensuring the CMC regulatory strategy is in alignment with the global/regional/commercial regulatory strategy.
Contributes to the implementation of global CMC regulatory strategies and dossier plans by collaborating with other CMC RA personnel.
Matching Summary
The Experienced Scientist Regulatory is responsible for supporting team members for a broad range of regulatory activities in the Chemistry, Manufacturing and Controls area of Global Regulatory Affairs.
Skills & Requirements
Must-have
CMC regulatory strategy
global dossiers/variations
Health Authority submissions
CMC country specific documents
global submission plan
responses to HA questions
Nice-to-have
proactively senses and responds
consistently delivers results
makes decisions based on facts
challenges the status quo
Key Requirements
minimum of 1 year of experience
drug development, analytical development or manufacturing preferred
global CMC regulatory procedures and guidelines/requirements
working in project teams and/or a matrix organization
Excellent oral and written communication skills
ability to work successfully within a collaborative team environment