Senior Manager, Regulatory Affairs

ComplianceComplianceFull TimeRemoteSeniorTeam 201-500Since 2013H1B SponsorCompany SiteLinkedIn

Location

California

Posted

3 days ago

Salary

$183K - $194K / year

Seniority

Senior

Bachelor Degree9 yrs expEnglish

Job Description

Senior Manager, Regulatory Affairs

Vaxcyte

• Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics. • Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines. • Manage preparation of responses to queries from regulatory authorities. • Ensure conformance to commitments made with various regulatory agencies. • Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks. • Manage coordination, preparation, and timely submission of regulatory documents and filings. • Review and approve change controls related to proposed product/process changes and assess their impact against regulatory requirements. • Cultivate productive working relationships with the Regulatory team and other departments. • Coordinate responses to CMC-related queries from Health Authorities.

Job Requirements

  • Bachelor of Science in a scientific discipline (Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices).
  • 9+ years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience.
  • Prior experience preparing/authoring CMC DS sections:
  • BLA highly preferred.
  • IND highly preferred.
  • IMPD.
  • Prior development or manufacturing experience is a plus.
  • Experience with module 32S and 32P.
  • Computer software skills (LIMS, SAP, TrackWise, Veeva will be used).
  • Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency.
  • Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Vaxcyte’s achievement of business objectives.

Benefits

  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

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