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Senior Manager, CMC Regulatory Affairs

Regulatory

US-Emeryville, CA OR Remote

Dynavax is a fully-integrated biopharmaceutical company dedicated to developing and commercializing innovative vaccines to prevent disease. Our vision and work ethic are guided by the collective ideals underpinning our corporate values, and these form the basis of our dynamic company culture. Our employees are based throughout the United States (including our headquarters in the San Francisco Bay Area) and our manufacturing facility in Düsseldorf Germany.

Manage CMC regulatory activities and submissions for assigned programs and be a regulatory representative on product teams. Lead regulatory activities, including the management of authoring, review, and coordination of submissions, as well as planning and executing meetings with regulatory agencies. Participate with RA Director/Sr. Director CMC to brainstorm innovative regulatory strategies that incorporate risk identification and mitigation.

Responsibilities

Represent Regulatory Affairs on assigned product/ project teams to communicate regulatory strategy and plans developed by the Director/Sr. Director CMC to gain alignment with team members, line management, and multiple stakeholders

  • Lead the preparation, planning and execution of aligned regulatory strategy through timely regulatory submissions
  • Oversee development of submission dossier content, associated documents and timelines
  • Provide critical review of all documentation supporting regulatory applications, provide gap analysis of submissions based on regulatory requirements; anticipate Health Authority responses and communicate areas of risk to project teams and line management
  • Lead meetings both in-person and teleconferences with regulatory agencies for specific projects; may also be required to work with government funding agencies
  • Negotiate complex issues with regulatory agencies and prepare responses to questions and comments from regulatory agencies
  • Ensure regulatory product compliance for assigned products (e.g. agency commitments)
  • As required, provide regulatory assessment for deviations, change controls and manage associated regulatory activities to ensure compliance
  • Interact with company partners and consultants for various regulatory matters as needed
  • As required, develop procedures to support the regulatory affairs department

Qualifications

  • Bachelor’s degree in a life science or related discipline required; advanced Degree (MS or PhD) highly preferred. Ideally a minimum of five years directly related experience in biotechnology or pharmaceutical industry. Minimum of two to three years direct experience in Regulatory Affairs.
  • CMC technical background in manufacturing, analytical, and validation
  • Must have product development and/or post licensure experience within Regulatory Affairs; experience with biologics and vaccines is preferred
  • Must have experience interacting with the FDA, EMA, Health Canada and/or other regulatory agencies
  • Ability to work on problems of diverse scope
  • Identifies priorities and key issues in complex situations and solves with minimal assistance
  • Exercises judgement within generally defined regulatory practices and policies
  • Experienced in leading cross-functional interactions related to regulatory matters
  • Effective in both written and oral communication
  • Able to direct work as required and manage complexity
  • Thorough knowledge of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)
  • Ability to anticipate and prevent potential issues
  • Understanding of regulatory issues and their touch points
  • RAC certification would be a plus
  • Business travel as required (10 -15%)
  • Ability to stand or sit for prolonged periods.
  • Must be able to perform repeating motions that may include the wrists, hands and/or fingers.
  • Full COVID-19 vaccination is required for this position.
  • Remote work is acceptable.

Dynavax is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.