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Intern - Regulatory

  • Internship
    Full-time
    Summer Internship
  • Government & Politics
    Research & Development
  • South San Francisco
  • Quick Apply

AI generated summary

  • You must be a current or recent student in science or engineering, have a passion for biotech, be organized and detail-oriented, and proficient in Microsoft Office programs.
  • You will support regulatory activities, assist with compliance documentation, enhance training tools, conduct research, and gain cross-functional exposure while showcasing your work with fellow interns.

Requirements

  • Currently enrolled undergraduate or graduate student or recent graduate with a major in science, engineering, or related field
  • Basic knowledge of healthcare industry and strong passion for biotech
  • Extremely organized, detail oriented and resourceful
  • Proficient in Microsoft programs including Outlook, Word, Excel, and PowerPoint

Responsibilities

  • Develop an understanding of the structure of and roles within a biopharmaceutical company and of the drug development process
  • Support the development of tools to enhance clinical process training and compliance
  • Assist with regulatory intelligence activities, including research, presentations, and development of communications tools
  • Develop regulatory skills required to assist in supporting clinical trial conduct and therapeutic program activities, including regulatory submissions and responses to health authority queries as needed
  • Support the maintenance of regulatory files and documentation to ensure compliance
  • Assist with development of new interdisciplinary processes
  • Gain cross-functional exposure to Regulatory CMC, Regulatory Advertising and Promotion, Regulatory Labeling, Regulatory Operations, Quality, and other functional areas
  • Assist with ongoing regulatory projects
  • Along with other Cytokinetics' summer interns, showcase your work through a presentation to the organization

FAQs

What is the duration of the internship?

The internship program is for approximately 12 weeks, beginning in late May/early June.

Is this internship paid?

Yes, this is a paid internship at our South San Francisco headquarters.

What are the key responsibilities of the intern in the Regulatory Affairs department?

The intern will support the development of tools for clinical process training, assist with regulatory intelligence activities, and help maintain regulatory files, among other tasks.

What qualifications are required to apply for this internship?

Applicants should be currently enrolled undergraduate or graduate students, or recent graduates with a major in science, engineering, or a related field, along with having a basic knowledge of the healthcare industry and a strong passion for biotech.

Will the intern have the opportunity to present their work?

Yes, along with other Cytokinetics summer interns, you will showcase your work through a presentation to the organization.

What software skills are needed for this position?

Proficiency in Microsoft programs, including Outlook, Word, Excel, and PowerPoint, is required.

Is there an opportunity for cross-functional exposure during the internship?

Yes, the intern will gain cross-functional exposure to Regulatory CMC, Regulatory Advertising and Promotion, Regulatory Labeling, Regulatory Operations, Quality, and other functional areas.

How can I verify the authenticity of a job offer from Cytokinetics?

Legitimate offers will come directly from our official email domain (Cytokinetics.com) and only after completing a formal interview process. If unsure, you can contact us at talentacquisition@cytokinetics.com.

Does Cytokinetics celebrate diversity in its workforce?

Yes, Cytokinetics values employees from diverse backgrounds and encourages applicants from all walks of life.

Are there any specific personal skills or traits preferred for this internship?

The ideal candidate should be extremely organized, detail-oriented, and resourceful.

Science & Healthcare
Industry
201-500
Employees
1998
Founded Year

Mission & Purpose

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, we are developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Proud to be a San Francisco Business Times Best Place to Work in 2021 and 2022, a Great Place to Work-Certified company in 2022 and a part of Fortune's Best Workplaces in the Bay Area in 2022 and Fortune's Best Workplaces in BioPharma in 2022.