Job for MPharm, BPharm in Regulatory Affairs, Quality Assurance at Casper Pharma
Casper Pharma is an emerging specialty pharmaceutical company focused on improving patients' lives by leveraging its global network to develop, acquire and commercialize pharmaceuticals that fulfill medical needs for the cardiovascular, gastrointestinal, urological, pain management and ophthalmic markets.
B. Pharma / M.Pharma with 2 to 6 years relevant formulation experience in Regulatory Affairs for US submission with following experience:
1. Author high-quality CMC documentation for US FDA submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruence and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
2. Prepare CMC responses to US FDA questions during development, registration and product lifecycle.
3. Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
4. Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
5. Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Actively participate as a member by contributing to the regulatory strategy, identifying the critical issues and lessons learned.