Proficient in Microsoft Office, strong communication and organizational skills, ability to work independently and collaboratively. Familiarity with cloud data management systems, ability to analyze and synthesize data, and knowledge of data visualization concepts. Pursuing a Bachelor’s Degree in computerized systems or life sciences, returning to school in the Fall Term or graduated within the past year. Available to work full-time and authorized to work in the United States.

The intern will support Global Regulatory Affairs by providing data management assistance, conducting business analysis to improve data quality, reconciling regulatory details, preparing labeling data for system migration, and assisting with operational change management activities.

IT & Cybersecurity

United States

San Rafael

Large

Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact.

Science & Healthcare

BioMarin Pharmaceutical Inc.

BioTech

We transform lives through genetic discovery.

<ul><li>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.</li><li>BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the global project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current global legislation, policies, guidelines and other regulatory intelligence.&nbsp;The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.</li><li>Within BioMarin GRA, the Regulatory Information Management and Technology Team supports a variety of Regulatory Information Management (RIM) tools and processes. Support of the greater Regulatory Affairs department includes stewardship of our Document Management and Regulatory Information Management systems and their related business processes. Some of the business capabilities under our stewardship are providing the tools and processes for managing the production of Regulatory Submission documents, their archival and retrieval, management of Health Authority commitments/correspondence, and maintaining a record of Registrations globally.&nbsp;</li></ul>

Currently Studying

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.BioMarin Global Regulatory Affairs (GRA) is responsible for obtaining approval for new BioMarin products and ensuring that approval is maintained throughout the product lifecycle. GRA serves as the interface between the regulatory authorities and the program teams aiming to ensure that the global project plan correctly anticipates what the regulatory authority will require before approving the product. It is the responsibility of GRA to keep abreast of current global legislation, policies, guidelines and other regulatory intelligence. The RA department plays an important role in giving advice to the program teams on how best to interpret the regulatory legislation and guidelines.Within BioMarin GRA, the Regulatory Information Management and Technology Team supports a variety of Regulatory Information Management (RIM) tools and processes. Support of the greater Regulatory Affairs department includes stewardship of our Document Management and Regulatory Information Management systems and their related business processes. Some of the business capabilities under our stewardship are providing the tools and processes for managing the production of Regulatory Submission documents, their archival and retrieval, management of Health Authority commitments/correspondence, and maintaining a record of Registrations globally. 

Intern, Regulatory Information Management and Technology

Requirements

Responsibilities

BioMarin Pharmaceutical Inc.

Mission & Purpose