Manager, Regulatory Affairs
Xeris Pharmaceuticals, Inc.
July 01, 2026
Remote friendly (Chicago, IL)
United States
Corporate Functions
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 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/biotech/CRO industry with a 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.
- Excellent project management skills.
- Experience with regulatory document management systems (e.g., Veeva Vault) is desirable.
Working Conditions
- Hybrid role (Chicago office); minimum three days per week in office; periodic evening/weekend work; periodic overnight travel.
Application Instructions
- For reasonable accommodations, email recruiting@xerispharma.com with the job requisition number.
- 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 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/biotech/CRO industry with a 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.
- Excellent project management skills.
- Experience with regulatory document management systems (e.g., Veeva Vault) is desirable.
Working Conditions
- Hybrid role (Chicago office); minimum three days per week in office; periodic evening/weekend work; periodic overnight travel.
Application Instructions
- For reasonable accommodations, email recruiting@xerispharma.com with the job requisition number.