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Intern, Regulatory (Clinical/Nonclinical)

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY:

The BioMarin Regulatory (Clinical/Nonclinical) group is looking for a motivated and productive Intern to support execution of submission activities for an early-stage development program. The intern will work closely with a talented team of regulatory professionals as well as cross-functional team members to understand the regulatory requirements to develop a drug and identify the appropriate approach to address and implement the regulatory plan.  The intern may also support U.S. product maintenance activities for commercial programs to broaden exposure to 1-2 marketed products.

JOB DESCRIPTION:

  • Prepare an orphan drug designation (ODD) application for early-stage development program in collaboration with the Global Regulatory Leader (GRL). This includes reviewing the ODD submission requirements and process, conveying requirements to the team, and leading authoring activities to prepare the application in line with expected timelines.
  • Provide IND submission support, including participating in regulatory team meetings, interfacing with cross functional team members to drive completion of responsible sections, and supporting related submission activities (ie, archival, QC of content etc…).
  • Support preparation of annual reports (ie, IND and/or PMR reports) for 1-2 commercial programs.

Qualifications/Eligibility:

  • Pursuing scientific undergraduate degree program
  • Knowledgeable of and/or experienced with requirements for orphan drugs, gene therapy products is a plus
  • Must be self-starter and able to work independently
  • Strong written and verbal communication skills
  • Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the intern program
  • Must be available to work 40 hours a week
  • Housing and Transportation is responsibility of the Intern

Benefits of a BioMarin Internship:

  • Apply skills and knowledge learned in the classroom to on-the-job experiences
  • Comprehensive, value-added project(s)
  • Work in teams and with colleagues in a professional environment
  • Develop technical skills specific to your major
  • Provides opportunities for professional development by building relationships and learning about other parts of the business
  • Weekly lunch seminar series with Executive Staff
  • End of summer poster presentation to the BioMarin Community

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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