Gland Pharma Hyderabad Vacancies | Regulatory Affairs Jobs in Hyderabad

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Vacancy for DRA – Labeling
Work location: Hyderabad
Experience: 4-6 Years

Job description:

1. Responsible for preparation and submission of CBE 0 labelling supplements for approved products to the US FDA
2. Responsible for eCTD submission, publication and product life cycle management
3 Draft preparation of text matter for artworks/Labels. Review and approval of artworks, change controls and updating for all regulatory submissions.
4. Initiation of change control regarding Artwork.
5. Compilation of eCTD modules and SPL publication to USFDA
6. Approval of artworks in software & print proofs.
7. Preparation, review and submission of customer import listing SPL’s

Interested in relevant can drop a CV to [email protected]

Thank you

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