Executive / Senior Executive – Regulatory Affairs / RA USA Formulation @ CASPER PHARMA PVT LTD
- Pharma / M.Pharma with 2 to 6 years relevant formulation experience in Regulatory Affairs for US submission with following experience:
- Author high-quality CMC documentation for US FDA submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
- Prepare CMC responses to US FDA questions during development, registration and product lifecycle.
- Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- 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.
- 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.
Senior Manager / AGM – Formulation Quality Assurance
B Pharma / M Pharma with 14 to 18 years relevant Formulation Quality Assurance experience with following expertise required.
- Shall be responsible for oral Quality management system
- Handing of site Quality operations includes engineering assurance ,mfg assurance and warehouse systems
- Oral inchage of GLP at QC and Microbiology lab.
- Heading of Qualifications and Validations of plant
- Leadership role to drive the Quality culture and businesses gole.
Interested Candidates Send CV to firstname.lastname@example.org
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