Regulatory Affairs Intern: Submissions & Coordination

Bristol-Myers Squibb Co; Indianapolis (IN); In loco; USD 33.000 - 62.000; Tempo pieno

Descrizione del lavoro

Bristol Myers Squibb Co in Indianapolis is offering a full-time Regulatory Affairs Intern for June–August 2027 at our Indianapolis site. You will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination in a cross-functional environment.

This internship provides exposure to regulatory processes in the pharmaceutical industry and hands-on experience with IND/CTA workflows, deadlines, and team coordination.

Competenze

• Currently pursuing a Bachelor's degree in Life Sciences, Pharmacy, Public Health, or related field.
• Strong interest in regulatory affairs and drug development.
• Excellent organizational and communication skills.

Mansioni

• Regulatory Documentation Support
• Assist in organizing and formatting regulatory submission documents (e.g., IND, CTA, briefing packages, nonclinical reports)
• Help maintain submission trackers and document repositories
• Review documents for consistency and completeness under supervision
• Project Coordination
• Support the creation and updating of project timelines and task lists
• Attend team meetings and take notes on action items and follow-ups
• Help prepare meeting agendas and distribute materials
• Cross-functional Communication
• Coordinate with internal teams to gather required documentation
• Draft internal communications and summaries for regulatory updates
• Shadow cross-functional meetings to understand regulatory integration
• Research and Compliance
• Conduct literature reviews and regulatory intelligence gathering
• Assist in compiling summaries of relevant FDA/EMA guidance documents
• Help monitor changes in regulatory requirements and flag updates to the team

Conoscenze

Regulatory interest

Organizational skills

Communication skills

Formazione

Bachelor's degree in Life Sciences, Pharmacy, Public Health, or related field

Strumenti

Microsoft Office Suite

Adobe Acrobat

Smartsheet

MS Project

Descrizione del lavoro

Bristol Myers Squibb Co in Indianapolis is offering a full-time Regulatory Affairs Intern for June–August 2027 at our Indianapolis site. You will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination in a cross-functional environment.

This internship provides exposure to regulatory processes in the pharmaceutical industry and hands-on experience with IND/CTA workflows, deadlines, and team coordination.