Senior Manager, Regulatory Affairs - Nationwide

Xeris Pharmaceuticals Inc; Georgia; On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

401(k) retirement benefits

Equity or long-term incentive awards

Job summary

Xeris Pharmaceuticals Inc. is seeking a Manager, Regulatory Affairs to lead regulatory activities supporting global clinical trials across all phases.

You will prepare and review submissions (INDs/CTAs), help shape regulatory strategy, and interact with internal and external stakeholders to ensure compliance with global health authority requirements. The role requires 5+ years in pharma/biotech with IND/CTA experience, a strong grasp of FDA/EMA/ICH/GCP, and excellent communication.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field.
• 5+ years of experience in the pharmaceutical/biotech/CRO industry with focus on clinical development.
• Demonstrated experience with INDs, CTAs, and global regulatory filings.
• Solid understanding of FDA, EMA, ICH, and GCP guidelines.

Responsibilities

• 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

Regulatory experience

Regulatory writing

Project management

Communication skills

Education

Bachelor’s degree

Master’s degree or PharmD preferred

Tools

Veeva Vault

Job description

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.

Benefits

Xeris offers a comprehensive benefits package that includes paid time off, health, vision, and dental insurance, 401(k) retirement benefits and more for eligible employees. Details will be provided at the time of a conditional offer.

Employees are eligible for equity or long‑term incentive awards, where applicable.

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 [e-mail] 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.

Recruitment Fraud Notice

Do not respond to unsolicited offers or requests for personal or financial information or fees. Xeris will never request such information. All legitimate recruiting communications will come from a @xerispharma.com email address.

Xeris participates in E‑Verify.

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.