Executive / Senior Executive - Regulatory
Affairs / RA USA Formulation @ CASPER PHARMA PVT LTD
Job description:
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 congruency 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.
Senior Manager / AGM - Formulation Quality
Assurance
Job description:
B Pharma / M Pharma
with 14 to 18 years relevant Formulation Quality Assurance experience with
following expertise required.
1. Shall be
responsible for oral Quality management system
2. Handing of site
Quality operations includes engineering assurance ,mfg assurance and warehouse
systems
3. Oral inchage of
GLP at QC and Microbiology lab.
4. Heading of
Qualifications and Validations of plant
5. Leadership role
to drive the Quality culture and businesses gole.
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