Senior Manager, Regulatory Operations
Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: May 14, 2022
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Job Description:
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. The Regulatory Operations Senior Manager may
have the role of Operations Lead for an assigned product/program
and oversee submission planning, including scheduling, resource
allocation, formatting, QC, publishing, transmitting, and archiving
regulatory submissions in both paper and electronic media to health
authorities in the US, EU, CA and Rest of World. In addition to the
oversight of systems and technical support as needed. The BioMarin
Senior Manager will support leadership in the development of
Regulatory operational objectives and work plans and will work
closely with functional management to obtain review and buy-in to
these plans. The Senior Manager will work collaboratively in a
cross functional environment on a diverse range of topics that
require in-depth Regulatory submission knowledge, understanding of
industry trends and analytical ability to develop options and
solutions for presentation to, and approval by, senior leadership.
Responsibilities Submission Planning Leadership and
Communication
Keywords: BioMarin Pharmaceutical Inc., San Rafael , Senior Manager, Regulatory Operations, Executive , San Rafael, California
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