Job Description
Key Responsibilities:
Regulatory Strategy and Submissions:
+ Develop comprehensive CMC strategies for early-stage programs and marketed products
+ Author and review regulatory submissions, including:
+ Investigational New Drug (IND) applications
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Post-approval variations/supplements
+ Annual reportsKey Responsibilities:Regulatory Strategy and Submissions:
+ Author and review regulatory submissions, including:
+ Investigational New Drug (IND) applications
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Post-approval variations/supplements
+ Annual reports
+ Responses to health authority questions
+ Ensure all submissions conform to relevant health authority guidelines and regulations
+ Lead submission preparation meetings and coordinate cross-functional input
...
Regulatory Strategy and Submissions:
+ Develop comprehensive CMC strategies for early-stage programs and marketed products
+ Author and review regulatory submissions, including:
+ Investigational New Drug (IND) applications
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Post-approval variations/supplements
+ Annual reportsKey Responsibilities:Regulatory Strategy and Submissions:
+ Author and review regulatory submissions, including:
+ Investigational New Drug (IND) applications
+ Investigational Medicinal Product Dossiers (IMPDs)
+ Post-approval variations/supplements
+ Annual reports
+ Responses to health authority questions
+ Ensure all submissions conform to relevant health authority guidelines and regulations
+ Lead submission preparation meetings and coordinate cross-functional input
...
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