Project Manager- Regulatory Affairs

  • location: San Rafael, CA
  • type: Contract
  • salary: $68 - $80 per hour
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job description

Project Manager- Regulatory Affairs

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!

location: San Rafael, California
job type: Contract
salary: $68 - 80 per hour
work hours: 9 to 5
education: Bachelors

  • Regulatory Business Operations
  • Provide project management support for various Regulatory Business Operations activities including, but not limited to, process teams, Regulatory Business Operations Committee (RBOC), Document Management teams, and other business systems and processes within Regulatory Affairs and support for cross functional teams as assigned.
  • Monitor Regulatory Business Operations correspondence, responding to quires, providing receipt of new document into process, and escalating issues.
  • Provide support for moving documentation through the procedure management system
  • Learn Regulatory processes and requirements across all Regulatory functions to be able to evaluate procedures for effectiveness
  • Implement initiative to consolidate department procedures, including, needs for revision, merging, or obsoleting procedures
  • Implement process improvement and procedures tracking and management, identifying and executing efficiencies and tools
  • Coordinate RBOC and other process team meetings, develop and distribute agendas, capture and distribute meeting minutes, following up on and track progress on action items
  • Liaise and align with stakeholders in Regulatory Affairs and cross-functionally on status and activities
  • Project tracking and metric reporting on RBOC and technology projects
  • Training and Curricula Management
  • Learning and development coordination and tracking, and maintenance of training curricula
  • Evaluate Regulatory training curricula for appropriate assignment for Regulatory functions by learning Regulatory processes and procedures identify any misalignment
  • Generate and distribute periodic reports and metrics regarding Regulatory procedures development and training performance for Global Regulatory Affairs to Associate Director of RBOP and Reg Leadership as directed
  • Collaborate with Regulatory functions, DSQ/Quest group to manage and update the global training curricula as needed.
  • Support training activities within Regulatory Affairs on document management, processes and policies, which may include, but not limited to, preparation of training materials, supporting live training sessions, set up of training rooms (in person and virtual)
  • Support the development and integration of Regulatory Affairs New Hire onboarding processes and procedures, which may include, development/revision of on-boarding forms/templates, supporting hire managers with new staff on boarding requirements and training and system set up
  • Documentation Management System Project Support
  • Support electronic Document management projects within Regulatory Affairs as assigned
  • Assist with data migration activities for a new Document Management System (eDMS)
  • Support document management process development teams including tracking of action items and follow up with SMEs on deliverables and timelines as assigned
Education & Qualifications:

  • BA/BS or higher in Biology, life or health sciences or related field preferred. Certificates or other education in Project Management, Regulatory Affairs or Regulatory Science a plus
  • 3+ years of relevant work experience in in Regulatory Affairs / Biotechnology or Pharmaceutical industries or relevant comparable background.
  • Thrives in an environment of cross-functional interaction and collaboration by highlighting interdependencies
skills: CMC, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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