Xeris Pharmaceuticals, Inc. · 6 days ago
Vice President, Regulatory Affairs
Chicago, IL
Full-time
Hybrid
Director/Executive
$300K/yr - $395K/yr
15+ years expXeris Pharmaceuticals, Inc. is seeking a Vice President of Regulatory Affairs to lead its global regulatory strategy. This role involves overseeing regulatory submissions, ensuring compliance, and leading a high-performing regulatory team while engaging with global health authorities.
BiotechnologyDiabetesHealth CarePharmaceuticalTherapeutics
Responsibilities
Develop, lead, and operationalize the global regulatory strategy across all development programs and marketed products
Provide strategic guidance to executive leadership, program teams, and cross-functional partners on regulatory pathways, risk mitigation, and emerging regulatory trends
Oversee the planning and execution of regulatory submissions, including INDs, NDAs, amendments, supplements, and annual reports
Guide regulatory decision-making to support clinical trial design, CMC programs, pre/clinical development, and post-marketing activities
Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory Operations, Labeling, and Advertising & Promotion
Provide ongoing coaching and feedback to team members
Establish departmental goals, operating procedures, and best practices that support scalable growth
Foster a collaborative, accountable, and high-integrity culture
Ensure regulatory processes and systems are scalable and optimize efficiencies while driving organization compliance
Serve as the primary company liaison with global health authorities (e.g., FDA, EMA, MHRA, PMDA), fostering positive, transparent, and strategic relationships across therapeutic areas, including endocrine disorders, general medicine, and rare diseases
Lead the preparation for and participation in meetings with regulatory agencies, including scientific advice meetings, Type A/B/C meetings, pre-IND interactions, and pre-submission meetings for both high-prevalence conditions and orphan indications
Drive regulatory strategies tailored to diverse disease landscapes, ensuring alignment with evolving guidelines for common chronic conditions (e.g., diabetes, thyroid disorders) and rare disease programs requiring accelerated pathways (e.g., orphan drug designation, breakthrough therapy)
Ensure timely, high-quality responses to regulatory inquiries and health authority requests, incorporating complex data packages from large-scale trials in common diseases and innovative designs for small-population rare disease studies
Collaborate cross-functionally to integrate regulatory considerations into clinical development plans, balancing standard-of-care expectations for general medicine with unique challenges in rare disease drug development (e.g., natural history studies, surrogate endpoints)
Provide regulatory leadership for combination products, including coordination of drug-device development strategies, compliance with FDA Combination Product regulations, and alignment of quality and safety requirements across components
Lead regulatory oversight for marketed products, including post-marketing commitments, label updates, safety reporting, and product changes
Ensure continued compliance with regulatory requirements related to labeling, advertising and promotion, product maintenance, and quality systems
Partner with Commercial, Medical Affairs, and Quality to support compliant promotional and medical communications activities
Collaborate closely with Clinical Development, CMC, Medical Affairs, and Commercial teams to ensure alignment of regulatory strategy with corporate objectives
Provide regulatory insights during portfolio prioritization, business development assessments, and external partnership discussions
Ensure adherence to all global regulatory requirements and internal SOPs
Maintain awareness of evolving regulatory landscapes and guide the organization in adjusting strategies and processes accordingly
Oversee audit readiness and support regulatory inspections as needed
Qualification
Required
Bachelor's degree required
15+ years of regulatory affairs experience within the pharmaceutical or biotechnology industries
Demonstrated success leading global regulatory strategies for products across phases of clinical development and commercialization
Proven track record interacting with regulatory agencies and health authorities (e.g., FDA, EMA)
Experience building and leading regulatory teams during periods of rapid company growth
Preferred
Advanced degree in a scientific discipline (PharmD, PhD, MS, or equivalent) preferred
Benefits
Eligibility for bonus and equity
Multiple paid time off benefits
Various health insurance options
Retirement benefits
Company
Xeris Pharmaceuticals, Inc.
We're a growth-oriented biopharmaceutical company improving patient lives by developing and commercializing advanced products across a range of therapies.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$548.5MKey Investors
Hayfin Capital ManagementArmistice CapitalDeerfield
2024-03-06Post Ipo Debt· $200M
2022-01-03Post Ipo Equity· $30M
2021-03-11Post Ipo Equity· $27M
Leadership Team
John Shannon
CEO and Director
Kenneth Johnson
Senior Vice President - Clinical Development, Regulatory Affairs, QA and Medical Affairs
Recent News
2026-01-09
The Motley Fool
2026-01-03
Company data provided by crunchbase