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Sr. Project Coordinator, Regulatory Affairs

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.

  • Executive Coordinator
    Support the Head of Reg Global Labeling/Reg Ops, as well as sub-functional leads including travel and expense reports and coordinating meetings
  • Provide administrative support exercising impeccable judgment and discretion in areas including time management, calendaring, creating and managing international/domestic travel itineraries and the preparation of expense reports for the individuals supported
  • Coordinate group meetings for Reg Global Labeling/Reg Ops including drafting agendas, run group meetings and generate minutes, track and follow up on action items, and support attendees to ensure they are prepared for meetings and fulfill their commitments in a timely manner
  • Track progress to action items for project-specific deliverables.
  • Maintain organizational chart
  • Maintain vendor expenses against budget and provide finance with support for monthly accruals
  • Order office supplies for Reg Global Labeling/Reg Ops which may include, but not limited to, special supplies for regulatory operations related to submissions and/or archiving

Regulatory Affairs Business Operations Coordinator

The Regulatory Affairs Business Operations Coordinator will support the Regulatory Affairs department with:

  • Learning and development coordination and tracking,
  • Process improvement and procedures tracking and management,
  • Technology implementation (metrics support and project tracking),
  • Document management special projects and on-going eDMS activities.

The successful candidate must be able to follow directions and multi-task on a wide variety of Regulatory business operations projects/tasks while simultaneously maintaining a high quality of work. 

Responsibilities will cover a range of Regulatory Affairs Business Operations areas as delegated and may include, but are not limited to:

Regulatory Business Operations Support and Project Management

  • Provide project management support for various Regulatory Business Operations activities including, but not limited to, process teams, Regulatory Business Operations Committee, Document Management teams, and other business systems and processes within Regulatory Affairs and support for cross functional teams as assigned.
  • Schedule team meetings, develop and distribute agendas, align team members, capture and distribute meeting minutes and follow-up on actions
  • Create and manage tools for tracking and reporting on team activities
  • Facilitate the identification of risks and management of issues; ensure follow-up, proper escalation and resolution
  • Liaise and align with Project Managers and stakeholders outside Regulatory Affairs on status and activities
  • Manage systems and tools for planning and tracking activities supporting key initiatives in Regulatory Affairs

New Hire Onboarding& Learning and Development

  • Support the Regulatory Business Operations Committee with the tracking and management of new or revised regulatory procedures, work instructions and tools
  • Support the development and integration of Regulatory Affairs New Hire onboarding processes and procedures
  • Serve as liaison between hiring managers and BioMarin facilities management group to ensure that department space related needs are addressed
  • Aggregate and streamline new hire forms, templates and system set-up
  • Support hiring managers on new individual hire plans and requirements.  Connect hiring managers to appropriate resources to ensure new hire needs are accommodated
  • Deliver training to Regulatory Affairs personnel regarding new hire onboarding processes, training and policies
  • Assist new hires with internal systems training, issue resolution and user access
  • Support the delivery training to Regulatory Affairs personnel on controlled document management, processes and policies
  • Process Regulatory Affairs SOPs through the existing controlled documents systems and collaborate with the Quality function to maintain and improve this process
  • Collaborate with Regulatory sub functions, DSQ/Quest group and Compliance Training to manage and update the global training curricula as needed
  • Set up and issue ComplianceWire assignments for new hire onboarding or on ad hoc basis
  • Generate and distribute periodic reports and metrics regarding Regulatory Affairs Compliancewire performance

Documentation Management

  • Serve as a point of contact for Regulatory Affairs documentation management
  • Support document management process development teams including tracking of action items and follow up with SMEs on deliverables and timelines
  • Provides support with external vendor management with template creation and management, under the guidance of Reg Operations.
  • Support the delivery training to Regulatory Affairs personnel on controlled document management, processes and policies, which may include, but not limited to, preparation of training materials, supporting live training sessions, etc.
  • Tracking document template status and managing the upload or retirement of templates into appropriate systems
  • Provides day-to-day support of the electronic document management system
  • Provides day-to-day operation support for departments (e.g. scheduling, reporting, records archiving)
  • Serve as a back up support to document archiving within Reg Ops

Cross functional projects

Contribute to cross functional improvement projects, as appropriate

Financial Management

  • Maintain financial information, templates and processes for Reg GL/Reg Ops, in collaboration with the corporate Finance group
  • Ensure Reg GL/Reg Ops groups adherence to contracting, PO set up and timely monthly accruals
  • Facilitate the conduct of vendor proposal review meetings
  • Enter requisition requests in Ariba to obtain POs for contracted services as needed by Reg Global Labeling/Reg Ops
  • Provide purchasing and accounting support and guidance to Reg GL/Reg Ops regarding contracting, purchase order and invoicing processes; liaise with accounting functions as required to troubleshoot and resolve issues
  • Support the Head of Reg GL/Reg Ops with monthly and quarterly performance v. budget and forecast analysis
  • Maintain Reg GL/Reg Ops groups’ vendor and contractor lists including key contact information and start dates

Competencies

An Coordinator demonstrates foundational core competencies across communication and collaboration and adaptability and flexibility.  For example:

  • Demonstrates the ability to distribute accurate information but may need guidance in appropriately crafting messages for target audience
  • Responds promptly to stakeholders, peers and management with clear and organized written and/or oral messages
  • Takes accountability for own team assignments and proactively offers support to  team members and team leaders when appropriate
  • Embraces new challenges or changed priorities and adjusts plans and priorities accordingly

The individual in this position is expected to be demonstrating foundational technical competence in service delivery orientation, project management, process management and systems, reporting and governance . For example:

  • Builds and maintains effective working relationships with Regulatory Affairs functional customers by responding in a timely manner and following through on commitments
  • Exhibits a solid understanding and independent execution of project management principles, tools, and techniques

Demonstrates familiarity with common process improvement tools and methodologies such as process mapping, root cause analysis and accountability/responsibility mapping

Clear, concise oral & written communication

Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies

Looks for best practices that can be leveraged in solution development

Education/Experience

  • BA/BS or higher in life or health sciences preferred. Certificates or other education in regulatory compliance a plus
  • 3+ years of relevant work experience in in Regulatory Affairs / Biotechnology or Pharmaceutical industries or relevant comparable background.
  • Experience in electronic document management, project management and/or learning and development
  • Excellent oral and written communication skills
  • Exhibits a good understanding of general quality assurance concepts and practices
  • Highly organized with a strong attention to detail
  • Successful history of solving problems of moderate complexity
  • Proven ability to manage both day-to-day operations, as well as project work in a fast-paced environment
  • Familiar with project management methodology and process
  • Possess strong computer and Internet skills, including online document management experience
  • Expert in Microsoft Office (Outlook, Excel, Word, & PowerPoint)


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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