Plan Review and Managing Regulatory Submissions like IND,IMPD, NDA, DMF and documents for regulatory advices.
Develop and execute regulatory plans for complex projects to enable efficient regulatory progression or maintenance in multiple global markets
Guidance to cross functional teams on regulatory expectations for US, EU, Japan and other major markets. Represent or lead the RA function on assigned cross-functional project teams
Monitor applicable regulatory requirements; assure compliance with internal and external standards. Review all the CMC, clinical , bio-analytical development related documents and ensure compliance to CTD requirements. Special focus on CMC regulatory.
Advanced degree (PhD, MS) in life sciences/Chemistry is required.
5-7 years experience in Plan Review and Managing Regulatory Submissions like IND,IMPD, NDA, DMF and documents for regulatory advices.
Good understanding about global regulations like ICH , USFDA, EMA, Canada, Australia , Japan etc.
Experience and Expertise to develop regulatory strategy from development stage to Filing and approval.