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Overview

The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing the company’s global regulatory strategy to support clinical development, product approvals, lifecycle management, and ongoing compliance. The incumbent will lead and grow a high-performing regulatory organization, serve as the primary liaison with regulatory authorities worldwide, and ensure that all corporate activities adhere to applicable regulatory requirements and industry standards. This role requires a strategic yet hands-on leader with deep experience in drug development, submissions, labeling, advertising and promotion, and post-approval compliance.

Responsibilities

Regulatory Leadership & Strategy

• 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.

Team Leadership

• 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.

Regulatory Agency Engagement

• 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.

Marketed Product Compliance & Lifecycle Management

• 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.

Cross-Functional Collaboration

• 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.

Governance & Compliance

• 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.

Qualifications

• Advanced degree in a scientific discipline (PharmD, PhD, MS, or equivalent) 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.

Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations and meet submission timelines. Travel up to 25% may be required to accomplish corporate goals and health authority requirements. This is a hybrid position based in Xeris’ Chicago office and a minimum of three days per week on-site is required. On-site requirement may change at management’s discretion.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

\#LI-HYBRID

_As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._

_The anticipated base salary range for this position is $300,000 to $395,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. 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_

_NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._

**Job Locations** _US-IL-Chicago_

**Title** _Vice President, Regulatory Affairs_

**ID** _2025-2325_

**Category** _Regulatory_

**Type** _Full-Time_