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Senior Associate, Regulatory Operations (TEMPORARY)

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. 

Duties


Please note that this role is different from a Senior Associate in Regulatory Affairs. Regulatory Affairs provides content of submissions and Regulatory Operations assembles the content per technical specifications and transmits to the Regulatory Agency.



Formatting and Publishing Able to independently format, publish, transmit and archive all submission types. Develop templates. Regulatory Intelligence Advanced understanding of regulations and guidances associated with submissions. Project Management and Communication Able to answer some technical questions for many submission types. Group Representation Attend RegulatorySub team meetings with main publishing contact to provide support. Technical Support Able to answer most technical questions for many submission types. Able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher.

Skills


The candidate should have at least 6+ years of experience in Regulatory Operations and must be certified in InSight Publisher or be able to provide training completion certificates from Liquent. Skills Required Basic computer skills in MS Office and Adobe Acrobat, experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment. Computer skills in InSight Publisher and Acrobat plug-ins such as ISI Toolbox, ability to publish routine submissions. Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions. Job Level/Complexity Uses professional concepts and company’s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Education


Bachelor’s Degree desirable.

Skills and Experience


The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education.


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.

About our location

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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