Intern - Regulatory Affairs

Location:  San Rafael, California Category: Regulatory Employment Category: Fulltime-Temporary

Description

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 Summer Internship Program will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, while gaining an insight into the pharmaceutical/biotech industry.

 

JOB DESCRIPTION:

Intern - Regulatory Project Research Analyst

This position will help the Global Regulatory Affairs team perform an analysis on all the global submissions they perform and assess the value of tracking each submission. The analyst will conduct interviews both inside and external to Regulatory to assess the value of the information and how timely notifications Health Authority submissions and approvals should be for each submission type.

For the proper candidate, the role could be expanded to assist with project management work on some of our marking applications and gene therapy development projects. This will depend on skills sets and project resourcing needs.

Qualifications/Eligibility:

  • Undergrad or Graduate Candidate pursing a degree in Science or Business
  • Knowledge of Microsoft Office suite products
  • Good communication skills required
  • 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:

  • Knowledge of the workings of Regulatory Affairs.
  • Comprehensive, value-added project, which will be the basis for setting Department Policy for submission tracking and communication
  • Work in teams and with colleagues in a professional environment
  • Ability to interface with many / most departments in BioMarin to determine communication flows for Regulatory information
  • Develop technical skills which will help your job search upon graduation
  • Provides opportunities for professional development by building relationships and learning about product development and keeping marketed products compliant
  • 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.