Manager, CMC Regulatory Affairs

Department
Regulatory Affairs

Location
San Diego

Summary Description
The Regulatory Affairs Chemistry, Manufacturing and Controls team (CMC RA) is responsible for providing all 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 be an integral part of, and hold a critical position on, the CMC RA team for assigned development programs and/or commercial products. The Manager will represent CMC RA on one or more product core teams, providing knowledge, advice and interpretation of applicable regulatory guidance’s and regulations. A key responsibility of the position will be to lead the planning and writing of CMC sections of submissions. The position will help ensure that CTD Module 3 and Quality Overall Summary Module 2 files are planned, drafted and driven to finalization within the required timelines and documentation standards.

Responsibilities:

  • Help guide the global development, registration, and life-cycle management of vaccines
  • Participate in decision making by creating and/or supporting innovative solutions to drug development and/or commercial lifecycle challenges
  • Plan and lead the writing of CMC CTD files for submissions for assigned programs
  • Define CMC content requirements for submissions, and ensure draft CTD files adequately meet established requirements and standards
  • Ensure project team colleagues, line management, and key stakeholders are apprised of developments and risks that may impact regulatory success
  • Evaluate change proposals reporting requirements for impact to dossiers

Requirements:

  • Several years of work experience in the Pharmaceutical/Biotechnology industry, in any of the following departments: Regulatory Affairs, Manufacturing, Pharmaceutical Development, or Quality Control.
  • Bachelors of Science Degree (E.g., Chemistry, Biochemistry, Engineering)
  • Experience supporting development and/or commercial products, with a history of successful Clinical Trial Applications and/or Market Applications
  • Strong team player that has a customer service approach and is solution oriented
  • Strong written and verbal communication skills, with attention to detail
  • Ability to work independently, and within a multi-disciplinary team
  • Experience working with all levels of management and consulting with key business stakeholders.
  • Established working knowledge of CMC guidelines and regulations (ICH/FDA)
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