Executive, Labeling Reviewer
Amneal Pharmaceuticals
- Location
- Ahmedabad, Gujarat, India
- Job type
- Full-time
About the role
Amneal Pharmaceuticals
Website:
amneal.com
Job details:
Job Description
- Compilation and/or initial review of labeling documents for OSD & Injectable for original ANDA and Additional strength submission.
- Co-ordinate with CFT for involvement and understanding of priorities and filing timelines.
- Follow-up with respective department to get documents in timely manner and to ensure that all labeling modules are available for submission on time.
- To be updated with current labeling practices and regulatory guidelines.
- Initial review of all deficiency & query responses related to US Labeling for both OSD and Injectable.
- To ensure that all labeling modules are available for CR, IR and DRL submission on time. Co-ordination with cross-functional teams as needed to collect required documents for deficiency responses.
- To compile deficiency responses.
- Must Have knowledge for threshold analysis (labeling part only).
- To achieve 100% launch readiness for all new products, with zero labeling issues. To ensure most recent and updated labeling has been issued Ok-To-Print. To ensure all printed labeling will be available for launch and on time. To ensure Drug listing of First Launch products after approval.
- To ensure labeling docs are available on time for successful execution of Site Transfer projects.
- To ensure labeling docs are available on time for successful execution of Additional Site Transfer activities.
- Introduction of labeling for Third party.
- Assist in review of all RLD updates of OSD & Injectable. To ensure that all labeling modules are available of RLD update for submission within time. To co-ordinate with supervisor for involvement and understanding of priorities.
- Initiation/Facilitate Change Control and LRC for all labeling changes.
- To approve Softcopy (vendor copy), transparency, shade card, First Print.
- To create Barcode Grade report.
- To address all annual reportable changes for labeling.
- To compile labeling templates for Annual Report, PADER, and APQR.
- Must have knowledge for Safety labeling change Notification.
- Good hold on Patent and Exclusivity for labeling carve out.
- Able to work on labeling SOPs.
- Must have good English communication skill.
Qualifications
B. Pharm/M. Pharm
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