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Xeris Pharmaceuticals
Manager, Regulatory AffairsXeris Pharmaceuticals • Chicago, IL, United States
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Manager, Regulatory Affairs

Manager, Regulatory Affairs

Xeris Pharmaceuticals • Chicago, IL, United States
30+ days ago
Salary
$120,000.00 yearly
Job type
  • Full-time
Job description

Manager, Regulatory Affairs

The Manager, Regulatory Affairs will be responsible for the management of regulatory activities supporting global clinical trials across all phases. This role will be responsible for preparing and reviewing regulatory submissions, contributing to regulatory strategy, and interacting with internal and external stakeholders to ensure compliance with global health authority requirements. The ideal candidate will have a strong understanding of regulatory processes and a proven ability to execute in a fast-paced, cross-functional environment.

Essential Job Functions

  • Lead and coordinate the preparation, review, and submission of clinical regulatory documents (e.g., INDs, CTAs, amendments, annual reports).
  • Support the development and execution of regulatory strategies for clinical-stage programs.
  • Collaborate with Clinical Operations, Medical Writing, and other internal functions to review and compile documentation for regulatory submissions (e.g., protocols, investigator brochures, clinical study reports).
  • Ensure regulatory submissions comply with applicable regulations, guidance documents, and internal standards.
  • Track submission timelines and status, ensuring on-time and high-quality deliverables.
  • Contribute to health authority interactions, including the preparation of meeting briefing documents and responses to information requests.
  • Monitor regulatory trends and changes in the global clinical regulatory landscape and communicate relevant updates internally.
  • Ensure accuracy and completeness of regulatory content in submission archives and tracking systems.

Skills and Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field (Master's or PharmD preferred).
  • 5+ years of experience in the pharmaceutical, biotechnology, or CRO industry, with a strong focus on clinical development.
  • Demonstrated experience with INDs, CTAs, and other global regulatory filings.
  • Solid understanding of global regulatory frameworks (FDA, EMA, ICH, GCP).
  • Strong written and verbal communication skills, with the ability to interpret and summarize complex scientific and regulatory information.
  • Excellent project management skills and the ability to handle multiple priorities and deadlines.
  • Experience with regulatory document management systems (e.g. Veeva Vault) is desirable.

Working Conditions

  • This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week in the office is required. On-site requirement may change at management's discretion.
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.

The anticipated base salary range for this position is $120,000 to $165,000.

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Manager, Regulatory Affairs • Chicago, IL, United States

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