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.
Interested Candidates Send CV to planthr@casperpharmaindia.com
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