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Analyst, Regulatory Affairs (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


Support the Global Regulatory Policy Team in the following regulatory policy activities:


* Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases.


* Provide project management support to the policy team in generation of comments on draft guidances;


* Track Team memberships and involvement in policy trade associations and organizations


* Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.


* Lead certain policy cross-functional meetings including minutes and action items


* Provide strategic logistical support for managing policy calendars and deliverables.


* Develop and manage internal policy publications.


* Develop and manage dashboards for policy team initiatives


* Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.


* Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.



Skills


Skills


* Experience in a regulated biotechnology or pharmaceutical environment; 1 year in Regulatory Affairs and/or policy


* Strong verbal and written communication skills


* Strong project management skills


* Proficient with computer and standard software programs


* Organizational skills


* Communication skills, excellent verbal, written and presentation skills


* Very strong attention-to-detail


Education


5 + Years of Experience


Bachelors or Masters Degree in biology or other life sciences discipline

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.

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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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