Senior Manager, Regulatory Affairs

Xerispharma; Chicago (IL); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Equity incentives

Comprehensive benefits package

Paid time off

Job summary

Xeris Pharmaceuticals, Inc. in Chicago is seeking a Manager of Regulatory Affairs to lead regulatory submissions for global clinical programs. You will steer INDs, CTAs, amendments, and annual reports, while shaping regulatory strategy and ensuring compliance across phases.

You will collaborate with Clinical Operations, Medical Writing, and other functions to assemble robust submissions, monitor timelines, and support health authority interactions as needed.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs or related field.
• 5+ years in pharma/biotech/CRO with clinical development focus.
• Experience with INDs, CTAs and global regulatory filings.
• Understanding of FDA/EMA/ICH and GxP guidelines.
• Strong written and verbal communication and project management skills.

Responsibilities

• Lead preparation, review, and submission of regulatory documents (INDs, CTAs, amendments).
• Develop and execute regulatory strategies for clinical programs.
• Coordinate with Clinical Operations and Medical Writing for submission documentation.
• Ensure submissions comply with regulations and internal standards.
• Track timelines, manage deliverables, and support health authority interactions.

Skills

Regulatory strategy

INDs/CTAs

Global regulatory filings

Regulatory communication

Project management

Education

Bachelor’s in Life Sciences/Regulatory Affairs

Master’s or PharmD preferred

Tools

Veeva Vault

Job description

## Manager, Regulatory AffairsApplyremote type: Hybridlocations: Chicago, ILtime type: Full timeposted on: Posted 5 Days Agojob requisition id: JR1020**Job Description:**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.*#LI-HYBRID *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, internal equity, market data, and the location of the role, where applicable.* *Xeris Pharmaceuticals, Inc. (the “Company”) is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. All qualified candidates are given equal opportunity and the Company’s employment selection decisions are based solely on job-related factors. NOTE: This job description is not intended to be all-inclusive. The employee may be required to perform other related duties as needed to meet the ongoing needs of the Company.**The level of the position will be determined based on the selected candidate’s qualifications and experience.* *Final determination of the actual base salary offered depends on several factors, including but not limited to the candidate’s skills, experience, education, location, and business needs. Employees are eligible for equity or long-term incentive awards, where applicable. Field Sales role employees are eligible for a quarterly commission structure. Non-Sales role employees are eligible for an annual bonus. The Company also offers a comprehensive benefits package that includes additional elements such as paid time off benefits, various health, vision, and dental insurance options, 401(k) retirement benefits and more for eligible employees. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. Individuals hired as temporary employees, interns, and preceptors are not eligible for commissions, bonuses, and/or long-term incentive or equity awards. Eligibility for other benefits will be based on plan documents.*