Gracure Pharmaceutical Ltd Gujrat Job Vacancy For DRA

Department:- DRA

Experience:- 4-10 years

Job Description: -

To compile the dossier in ctd and actd format as per the regulatory requirements of regulated markets (europe/uk/ canada/australia).
Collaboration with R&D, Partners and other stakeholders to enable development in line with regulatory requirements. Well verse with regulatory guidelines of main regulated body such as ICH, WHO, EMA etc.
To arrange the documents from different stakeholder and review the documents as per RA adequacy to provide the quality dossier for submission to partner as per the predefined timelines.
Assess the change control for regulatory adequacy and requirements. To ensure the life cycle management of product to smoothen the market supply of product.
Review the drug master file of active ingredients as per regulated and semi-regulated markets requirements.

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