Manager, Regulatory Affairs

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.
• The position may require periodic evening and weekend work, as necessary to fulfill obligations.
• Periodic overnight travel may be required.

Pay

The anticipated base salary range for this position is $120,000 to $165,000. We are committed to offering competitive compensation. Starting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, location, and business needs.