Manager/Sr Manager - RA Labeling - US - Pune

Emcure

7 - 10 years

10 - 17 Lacs

Pune

Posted:3 weeks ago| Platform:

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Skills Required

Artwork Labeling

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role: The primary responsibility of this position is to prepare, review and approve pharmaceutical labeling for US generic drug products. This includes container labels, cartons, package insert, medication guides etc. The individual is responsible for ensuring Labeling meets US FDA requirements and internal timelines.

JD:

Create draft labeling for new generic drug product labeling for submission in ANDAs to US FDA.
Work with multiple printers for creation of artwork and final print labeling.
Create/manage SPL files. Ensure drug listing is up to date and accurate.
Initiate changes for labeling as required
Ensuring annual drug listing certifications are completed accurately and in accordance with US FDA stipulated timeframes.
Initiate Change Control for labeling changes
Review and approve labeling for submission and for printing as required

Ensure labeling is up to date with current Reference Listed Drug Labeling
Ensure complete and accurate Regulatory files for Labeling
All other duties assigned by Manager.

Qualification/Experience:

B. Pharm / M. Pharm required.
US Generic drug Regulatory Affairs Labeling experience required
Generic drug labeling experience required
Knowledgeable in US FDA Labeling required
Prior SPL experience required
Prior Use of FDA Xforms preferred but not required
Prior use/knowledge of GlobalVision preferred but not required

If relevant and interested pls share your resume.

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