Company: Delta Biopharma Pvt Ltd
Post: Executive/Sr executive regulatory affairs
Experience: 4-8 yrs
Qualification: Lifesciences graduates
Location: Mumbai
Roles and Responsibilities
- Product Registration
- Experience filing ACTD dossier for Nutraceuticals/ health supplements for APAC and African countries.
- Assist in the preparation, review and submission of various CTD and ACTD pharmaceuticals & nutraceuticals dossiers for ROW/African and Indian Market.
- Review and maintain regulatory documentation in databases or systems
- Artwork Development activities.
- Reviewing of all the documents as a part of the registration administrative section & Chemistry, Manufacturing & Quality Control documents (CMC) section like Drug Master File, Specifications, Method of Analysis, and Certificate of Analysis, Product Development Report, Process Validation, Analytical Method Validation, Batch Manufacturing Record and Stability Data, etc. with respective of their approvability from the agency.
- Preparation of package inserts, a summary of product characteristics and patient information leaflet.
- ICH quality guidelines
- Application of COPP for Exporting country
- Arrangement of product samples as per country guidelines/client requirements.
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