Manager, CMC Regulatory Affairs

Department
Regulatory Affairs

Location
San Diego

Job Purpose:

PaxVax’s Chemistry, Manufacturing, and Controls Regulatory Affairs (CMC RA) team is responsible for providing all of the CMC Regulatory leadership and global strategy required to achieve and maintain country product licenses. As a strategic function, CMC RA collaborates closely with multiple scientific, technical, quality, and commercial areas within PaxVax and/or with external Contract Manufacturing Organizations (CMOs).

The Manager will play a key role on the CMC RA team with focus on manufacturing processes and controls for assigned development programs and commercial products. In this role the Manager will help to provide knowledge, understanding, interpretation and utilization of applicable regulatory guidance’s and regulations, as well as industry and government agency best practices and trends. A key component of the position will be to ensure that CMC sections of submissions are planned, drafted and driven to finalization within the required timelines and documentation standards.

Responsibilities:

  • Provide strategic CMC guidance for the global development and registration of vaccines
  • Help to create innovative CMC solutions while being an advocate for compliance
  • Plan, execute and manage CMC sections of submissions for assigned programs
  • Define CMC content requirements for submissions and help to create and review such content for conformance with established requirements and standards
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success
  • Evaluate change proposals for dossier impact and reporting requirements

Requirements:

  • Ten years of work experience in Pharmaceuticals/Biotechnology in Regulatory Affairs (CMC) Manufacturing, Pharmaceutical Development, or Quality Control.
  • Bachelors of Science Degree (Chemistry, Biochemistry, Engineering)
  • Experience supporting both development projects and marketed products, with a history of successful Clinical Trial Applications and Market Applications
  • Established working knowledge of CMC guidelines and regulations (ICH/FDA)
  • Strong team player that has a customer service approach and is solution oriented
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • Possesses strong written and verbal communication and presentation skills
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
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