Regulatory Affairs - US -Executive

Shilpa Medicare

2 - 7 years

2 - 7 Lacs

hyderabad

Posted:4 hours ago| Platform:

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Skills Required

ectd osd europe labelling toc module 1 us market ra ich usfda canada regulatory affairs anda formulation cmc dmf

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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