NEED ONLY H1B WITH PASSPORT NUMBER
Hi,
Pleasure mailing you. Please go through the below requirement and let me know if you are comfortable for the position.
Please send me your updated resume along with the best hourly rate, work authorization status and availability.
An early response is really appreciated.
Job Title: US Labelling Operation Consultant
Location: Remote
Duration: 9+ Months
This person should be very knowledgeable about US FDA requirements to do the below activities;
- Timely and accurate implementation of US labeling changes
- Participation to the preparation of elements for submission to Health Authorities (Registered products/NCE/ line extension/Early Access)
- Develops text for cartons and container labeling
- Performs QC on product information (US PI..) before submissions to Health authorities
- Interacts with the FDA and national agencies as contact point for US carton and container labeling
- Provides instructions for industrial implementation to manufacturing and coordinates response in case of questions
- Acts as US Affiliate RA team member with regards to initiating US artwork updates and validates the revised artwork
- Mark-ups for development of label artwork.
- Prepare regulatory agency labeling submission documents, including but not limited to final content of labeling, SPL, and annual reports.
- Prepare labeling change controls as needed.
- Reviews and updates text in submission cover letters to ensure correct information is included.
- Prepare new and maintain SPL.
- Ensure assignment of NDC numbers as appropriate
- Ensure printed labeling proofs are in compliance with all US regulatory requirements. This includes cartons, containers, USPI, PPI, IFU, MedGuide, etc.
Thanks,
Ch Anvesh Kumar
US IT Recruiter
LinkedIn: https://www.linkedin.com/in/anvesh-kumar-chitithoti-16780b24a/
Email: Anveshc@tekskillsinc.com | www.tekskills.in
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