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Associate, Regulatory Affairs CMC III (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


Coordinating the planning, preparation and submission of global regulatory CMC-related submissions for clinical and commercial products such as: post approval variations, Marketing Application(s), Annual Reports, Clinical Trial Applications, and amendments.


Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.


Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time.


Performing regulatory research and drafting reports summarizing regulatory requirements.


Proactively identifying issues and suggesting appropriate strategies to mitigate risks.


Ensuring consistent and appropriate communication within the department and with other functional areas.


Interfacing with global Regulatory partners, internal cross functional teams, and consultants.


Attending relevant functional area and project team meetings.


Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.


Skills


5+  years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products).


Thorough understanding of relevant drug development regulations and guidelines (ie, FDA regulations and ICH guidelines) as well as an understanding of CGMP.


Outstanding interpersonal and communication (written and verbal) skills is required.


Strong writing and editing skills for technical documentation.


Experience with devices or combination products a plus (ie, HFA evaluations, FMEAs).


Effective task planning and coordination abilities.


Proficient with computer and standard software programs.


Education


BA/BS degree in life sciences, chemistry, molecular biology, or similar is desirable. Advanced degree is a plus.


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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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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