Description
Job Description* CMC development and global submission strategies for Clinical trials, New submissions and Post-approval CMC changes.
* Manage lifecycle submissions including Amendments, Variations, Gap analysis, Renewals, Annual reports, Supplemental submissions, and CTD updates.
* CMC project management including conceptualization, non-clinical development, clinical development, CMC submissions, commercialization, launch and post-approval maintenance.
* Contribute to development of technical development plan, development reports, design of experiment (DOE) studies, manufacturing process development and controls, scale-up reports, technology transfers, process validation plan, specification setting and justifications, analytical method validation, packaging development, stability programs and comparability programs.
* Manage Regulatory submission publishing for electronic submissions and eCTD compliance.
* Stakeholder management (internal and external including Country offices and Health Authorities).
* Maintenance of electronic systems for Regulatory Compliance.
* Function as Regulatory Intelligence.
Requirements
* University degree in Science/Pharmacy
* A minimum of 5 years of experience in Regulatory Affairs
*Proven advanced technical and regulatory writing experience with pharmaceuticals.
* Excellent understanding of regulatory processes and requirements in US, EU, JP, Canada, and EU National applications.
To find out more about Real please visit www.realstaffing.com