Overview
Skills
Job Details
Hello,
I Hope you are doing well.
This is Surya from Humac Inc., Please check the following job description, and if you are interested, or know someone who might be interested, please share your updated resume to reach you.
Role: Structured Product Labeling(SPL), Regulatory Affairs
Location: New Jersey(Remote)
Duration of the project: 12+ Months Contract
Responsibilities
Review of SPLs content labelling
Submission of SPLs content labelling
Monitoring of recent updates in SPL
Escalate, notify and resolve any issues that may impact final submission.
End to end responsibility/ management of product registered in USA market.
Responsible for maintaining internal tracker for SPL submissions.
Qualifications we seek in you!
Minimum Qualifications / Skills
B. Pharmacy
M. Pharmacy
Preferred Qualifications/ Skills
Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.
Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.
Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.
Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.
Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.
Depending on experience level, mentor newly hired staff or lead a team of junior staff.
Flexibility in responding to changing priorities or dealing with unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
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Best Regards,
Sai Surya Teja
US IT Recruiter
Humac Inc.
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Phoenix, AZ 85027