...regulatory authorities) on defined matters.
·
Face external audits / inspection, coordinate and communicate with external auditors / inspectors for compliance.
Qualifications
Expertise in regulatory compliance ...
...Regulatory Affairs Specialist is responsible for submitting relevant information to various regulatory agencies to obtain approvals for Cook products
Coordinate and Manage timely Regulatory Submissions between l...
...it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically... ...to prepare responses to questions.
Implement a...
...labeling materials with the Generics Law and other relevant laws.
c) Ensure regulatory support to GMP inspections if required
d)... ...relevant regulations (e.g. FDA
EMA).
Profici...
About the role
Your responsibilities include, but are not limited to:
• Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Su...
Executive to Deputy Manager
Years of Experience : 4 -10 years
Qualification: Should be M.Sc. (Organic Chemistry) or Equivalent
Competencies Required
Chemistry Knowledge ( A foundational understanding of chemistry and should be able...
...Employment Type: Full Time, Permanent
Education
UG: Any Graduate
PG: Any Postgraduate, MBA/PGDM in Any Specialization
Doctorate: Doctorate Not Required
Skills: regulatory affairs,publishing,electr...
...Job Description
Job Description
Assistant Manager, CMC
Assistant Manager, CMC – Regulatory Affairs will be a part of the GRACS... ...language skills are a plus.
Our Regulatory A...
...reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all Novartis requirements for submission-related activities
Proactively identify issues, gaps, and trade-offs ...
Precision for Medicine have an exciting opportunity for a Manager, Safety Submissions / Reporting to join our team This position is based remotely in India.
Precision for Medicine is a precision medicine CRO. Precision's ...
Pune
Precision For Medicine
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