Manager, Regulatory Affairs

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.

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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.

Accessibility & Reasonable Accommodations

If, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to recruiting@xerispharma.com and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message. Please note if your request is not for this stated purpose, you will not receive a response to your email. Do not include any medical or health information in this email.

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