Intern - Regulatory Affairs, CMC

Overview

On Site
Hybrid
$21.05 - $31.5 hr
Full Time
Contract - W2
Contract - Independent
Contract - 12+ mo(s)

Skills

Regulatory Affairs
Product Development
Manufacturing
Information Management
Process Improvement
Crystal Management Console
Communication
Organized
Attention To Detail

Job Details

Title: Intern - Regulatory Affairs, CMC

Location: Regional description (Onsite)
Employment Type: Contract

Compensation
Pay Range:$22.05-$31.50/Hrs

Description:
* Support regulatory projects by collaborating with cross-functional teams.
* Develop a deeper understanding of drug development and regulatory requirements.
* Gain exposure to global Regulatory Affairs and CMC Regulatory Affairs.
* Learn about the role of global Health Authorities in drug development.
* Prepare regulatory documents for submission to global health authorities.
* Experience CMC technical product development and manufacturing functions.

Key Responsibilities:
* Maintain accurate CMC information in the Regulatory Information Management system.
* Create and maintain CMC submission content and upload correspondence.
* Contribute to process improvements in Regulatory CMC.
* Draft CTD CMC sections for global applications.
* Provide support to the Regulatory CMC team with submissions and tasks.

Qualifications:
* Active enrollment in a graduate or Ph.D. program in a scientific discipline.
* Minimum 3.0 GPA.
* Strong written and oral communication skills.
* Organized, responsible, resourceful, and detail-oriented.
* Able to work independently and in a cross-cultural team environment.

Contact Information:
Kaushik Podishetti,

Benefits:
Learn more about our benefits offerings here

EEO Statement:
Learn more about our EEO policy here

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