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Intern - Regulatory Affairs

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. 

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 Business Operations and Processes (RBOP)

The RBOP Intern will support the Regulatory Affairs department with input and management of important initiatives within the department. This is an opportunity to learn and have an impact on Regulatory processes and information that is submitted to health authorities globally. Department initiatives are in the following areas;

Management of information that is submitted to health authorities:

This is an opportunity to learn about functions across BioMarin, and understanding their processes and submission requirements. This position will assist with data migration activities for a new Document Management System (eDMS) by verifying meta data for documents in existing system is complete and accurate and confirming document migration into the new system was successful. Will provide document management for implementation of the eDMS with metrics and project tracking, working with all Regulatory functional groups and a cross-functional team to assess procedures needing revision, track and manage those identified, assuring the Regulatory procedure revisions are done in a timely manner by liaising with the Regulatory Business Operations Committee members.

Department Procedures Process and Management:

This position will support the Regulatory Business Operations Committee (RBOC) and will learn about Regulatory processes, requirements and regulation across all Regulatory functions by management and tracking of new or revised regulatory procedures though the RBOC and controlled document system, and will collaborate with the Development Sciences Quality (DSQ) department for evaluating the process for improvement. This position will provide project management support by track action items and follow up with SMEs on deliverables and timelines.

Learning and Development:

This position will assist the Regulatory department by evaluating the Regulatory training curricula for appropriate assignment for Regulatory functions by learning Regulatory processes and procedures then identify any misalignment, and provide periodic reports and metric regarding training performance. This is an opportunity to collaborate with Regulatory functions, DSQ/Quest group to manage and update the global training curricula as needed. Additionally supporting the delivery of training to Regulatory Affairs personnel on controlled document management, processes and policies, which may include, but not limited to, preparation of training materials, supporting live training sessions.

Qualifications/Eligibility:

  • Pursuing a Bachelors or Master’s or PhD degree in Biology/life sciences or in a related field of study with minimum of first year completed
  • Pursuing a Master’s degree or certification in Regulatory Affairs or Regulatory Science a preferred
  • Experience in electronic document management, project management and/or learning and development a plus
  • Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies
  • Can identify best practices that can be leveraged in solution development
  • Highly organized with a strong attention to detail
  • 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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San Rafael

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