Job Description

Hello There,

My name is Himanshu Sharma , and I serve as the Recruitment Lead at Kanak-IT INC. I am reaching out to share an excellent career opportunity for the role of Regulatory Compliance Specialist with our esteemed client. If you are interested then please share your updated resume at Himanshu01@kanakits.com .

Job Description

Position : Regulatory Compliance Specialist

Location : Swiftwater, PA Hybrid

Duration : Long term contract

Must have 2-6 years of relevant experience in the Pharma/Biologics industry.

REQUIREMENTS for the Regulatory Compliance Specialist:

• Bachelor s degree in Biological Sciences OR Master s degree in Regulatory Affairs/Quality Assurance
• 2-6 years Pharma or Biologics industry experience in Quality and/or Manufacturing
• Knowledge of healthy authority and vaccine regulations .
• Requires knowledge and understanding of CMC topics , as well as North American, European and International regulations/guidelines
• Experience authoring regulatory documents (modules 1.2, 2.3 and 3)
• Ability to manage multiple priorities efficiently
• Microsoft Suite experience
• Vault Database experience(experience in Vault DB would be helpful).
• Experience working on Project teams
• Demonstrated knowledge of microbiology, immunology, virology or bacteriology
• Excellent skills in communication, writing and teamwork

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