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Manager, Regulatory Operations

Location San Rafael, California Workstyle Open to Hybrid
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.

Summary

The Regulatory Operations 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.

Responsibilities

Submission Planning Leadership and Communication

  • Oversee the development and maintenance of processes, templates, standards, and guide sheets
  • Independently format, publish, transmit and archive all submission types; maintain templates
  • Track status of submissions and project assignments; provide status updates and other communications to Regulatory Operations Management
  • Manage timelines for submission calendar
  • Participate in GRT and related sub-team meetings as needed and ensure adequate follow-up

Technical support

  • Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs
  • Trouble shoot complex system user issues (such as interpreting technical validation errors)

Additional Responsibilities

  • Stay abreast of new guidances released by health agencies and coach team members on interpretation as needed
  • Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidances
  • Support due diligence activities and audits when necessary
  • Function as main contact for submission templates, and formatting standards

Required Skills

  • Must be highly proficient in MS Office 365 (with an emphasis on MS Word)
  • Experience with Adobe Acrobat (version XI Pro or DC preferred) and publishing related plugins such as ISI Toolbox
  • Strong knowledge of eDMS and eCTD Publishing Systems (VEEVA RIM) and InSight Publisher preferred).
  • Must have extensive experience with electronic submissions, specifically eCTD

Education & Experience

  • Degree in health or life sciences, including chemistry, molecular biology, or similar.  PhD preferred, Masters/Bachelors acceptable with relevant experience
  • 2 + year experience with PhD; 4+ years with Masters, 6+ with bachelor’s degrees
  • Must have extensive experience with electronic submissions, specifically eCTD

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, 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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