Regulatory Affairs
6 days ago
Role & responsibilities
CMC and Labelling:
- Preparation of ANDAs in eCTD format for various type of formulations
- Review of the technical documents such as Specifications, BMR, MFC,
- Able to work on All type of CTD section write-ups
- Hands on experience on life cycle management activity (AR, CBE, CBE-30 and PAS)
- Through knowledge on ICH guidances
- Should able to handle Module -I related activities
- Able to review Drug substance DMF and should prepare a due diligence
eCTD Related activities:
Complete knowledge on eCTD related publishing activities
Practical knowledge on PDF attributes such as book marking, intra inter hyper ink, file destination TOC's etc., should adhere to FDA published latest guidance
- Creation of eCTD sequence
- File names per requirement
- Uploading the documents for new sequence and knowledge on Append, add replace attributes for LCM products
- External hyperlinking from the server
- Should able to handle the errors that encounters during publishing
- Practical knowledge on inbuilt and other approved validator (Lorenz )
Preferred candidate profile
Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada
Perks and benefits
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