Regulatory Affairs Intern - Hybrid/Remote at Be The Match in Minneapolis, Minnesota

Job Description:

Please apply online using a laptop or desktop computer.

POSITION SUMMARY:

We are seeking a motivated and detail-oriented Regulatory Affairs Intern to play a key role in the transition of paper-based Investigational New Drug (IND) submissions to a fully electronic system. This position will be instrumental in supporting the Regulatory Affairs team by assisting in the creation of structured templates for regulatory data and contributing to the development and organization of a dedicated regulatory SharePoint page. In addition to these core responsibilities, the intern will gain comprehensive exposure to regulatory frameworks governing cell and gene therapy products, providing a unique opportunity to deepen their understanding of the biopharmaceutical industry's regulatory landscape. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid

Check out our video Saving Lives: It's the Best Job Ever

ACCOUNTABILITIES:

• Digital Transformation of Submissions: Collaborate with the Regulatory Affairs team to convert paper-based IND submissions into a standardized electronic format, ensuring compliance with FDA and other regulatory body requirements.
• Template Development: Assist in the creation and refinement of regulatory templates to streamline future presentations and submission processes, promoting efficiency and consistency across documentation.
• SharePoint Development: Play a supporting role in the design, organization, and maintenance of a regulatory SharePoint site, aimed at centralizing regulatory documents, resources, and submission data for internal stakeholders.
• Regulatory Insights: Gain hands-on experience with regulatory requirements specific to innovative therapies, such as cell and gene therapies and relevant US FDA regulations/guidance (e.g., 21 CFR 1271, 21 CFR 211, 21 CFR 312, etc.).
• Cross-functional Support: Provide support to the Regulatory Affairs team for additional activities as needed, such as preparing for regulatory meetings, and assisting with project tracking and reporting.
• Other duties as assigned.

• Strong organizational skills and attention to detail.
• Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint).
• Ability to work independently and in a team environment.
• Interest in regulatory affairs, biopharmaceuticals, or healthcare industries.

Education and/or Experience:

• Currently pursuing or recently completed a degree in life sciences, regulatory affairs, or a related field.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Experience or coursework related to regulatory affairs or the biopharmaceutical industry.
• Basic understanding of regulatory submission processes and document management.
• Familiarity with SharePoint or other shared network platforms.

DEI COMMITMENT:

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.

BENEFITS:
NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information