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 and contributes to the implementation of global CMC regulatory strategies.
Proactively senses and responds to problems and opportunities, consistently delivers results that meet or exceed expectations, and makes decisions based on facts.
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 alignment
global dossiers/variations preparation
CMC submissions for renewals
CMC country specific documents management
global submission plan oversight
responses to HA questions
Nice-to-have
patient-centric approach
innovative medicine development
collaboration with senior personnel
proactive problem-solving
Key Requirements
Minimum 1 year of experience
University degree in engineering, biological, pharmaceutical, or chemical sciences
Prior experience in drug development, analytical development or manufacturing preferred
Experience with global CMC regulatory procedures and guidelines/requirements
Experience in working in project teams and/or a matrix organization