Global Regulatory Operations Publishing | Undergrad Intern ~ Summer 2024
Are you a detail-oriented student eager to gain hands-on experience in Regulatory Operations and global health authority submissions? This internship offers a unique opportunity to contribute to the preparation and delivery of high-quality, timely, and compliant regulatory submissions in a fast-paced, cross-functional environment.
As a Global Regulatory Publishing Undergrad Intern, you will:
- Support regulatory submission preparation and delivery to global health authorities.
- Collaborate with cross-functional teams to ensure submission compliance and accuracy.
- Gain exposure to regulatory processes, industry best practices, and global submission standards.
- Contribute to regulatory initiatives and provide support across various projects.
location: Telecommute
job type: Contract
work hours: 9 to 5
education: Bachelors
responsibilities:
- Collaborate in submission teams, to assist planning and execution of timely regulatory submissions primarily in eCTD format in support of investigational and marketed products.
- Represent Global Regulatory Publishing as subject matter expert on regulatory teams and project teams
- Ensure compliance with global health authority regulations, guidelines, and specifications including FDA, EMA, Health Canada, and ICH for regulatory submissions.
- Contribute to submission plans to develop, track, and report on submission deliverables for all submissions
- Facilitate submission QC and issue resolution for regulatory submissions and documents with stakeholders
- Identify potential risks to submission plans, escalating appropriately
- Support report publishing, QC, and signoff utilizing templates and eSignature technology in accordance with company process and standards
- Assist in development of documentation including job aids or best practices.
- Maintain records and data in Regulatory Information Management (RIM) system
- Performs other regulatory related duties as assigned
qualifications:
- Enrolled in program progressing toward BS/BA (Reg Affairs)
- Interest in creating and publishing regulatory submissions for Investigational (IND, CTA) or New Drug , NDA, BLA, MAA, and other filings to Global Health Authorities in eCTD format
- Ability to research and interpret global health authority regulations, including FDA, EMA, Health Canada, and ICH guidelines
- Technical aptitude to quickly learn industry tools such as eSubmission Gateway, DXC ToolBox, Lorenz docuBridge, Accenture Starting Point templates, and Veeva Vault
- Ability to work independently with moderate supervision on multiple projects
- Strong team building, creative problem solving and troubleshooting skills
- Strong verbal and written communication skills
- Full-time availability for the duration of the internship
- US Work authorization for the duration of the internship
skills: NDA, FDA, Maa, CTA, Regulatory Affairs Operations, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
