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Regulatory International Project Manager (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



    • Manage Regulatory International operations including scheduling and facilitating meetings with Regulatory International team members and Global Regulatory team members (schedule, prepare/distribute documentation and ensure action item follow-up).

    • Create and maintain Regulatory International timelines for new Marketing Applications and lifecycle management activities, and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.

    • Liaise with Regulatory Project Managers and Global Regulatory team members to ensure timelines are integrated to reflect cross-functional dependencies

    • Create and maintain reporting dashboards for teams and management.

    • Monitor submission preparation progress to ensure timely filing to health authorities.

    • Document project milestones/deliverables and report progress against team, department, and corporate goals.

    • Facilitate short and long-term planning activities.

    • Maintain product registration tracking information for assigned projects in collaboration with Regulatory Project Managers.

    • Establish personal operational objectives and independently manage workday to ensure they are achieved.

Skills



    • Minimum 3 years of experience in a project management or scheduling environment

    • Ability to successfully manage multiple projects to deadlines.

    • Knowledge of Regulatory Affairs submissions and nomenclature desirable.

    • Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.

    • Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.

    • The candidate should possess the ability to work as part of an interdisciplinary team, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.

Education



    • Bachelor’s degree required.

  • Project Management Professional and/or Regulatory Affairs Certification a plus.


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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