---
title: 'GVP, Global Regulatory Affairs at Kiniksa Pharmaceuticals'
canonical: 'https://feeny.ai/job/gvp-global-regulatory-affairs-kiniksa-pharmaceuticals-lexington-4v9qahg1fnxq'
type: 'job'
last_seen: '2026-11-02'
---

# GVP, Global Regulatory Affairs at Kiniksa Pharmaceuticals

- **Company:** Kiniksa Pharmaceuticals
- **Location:** Lexington, MA
- **Compensation:** $360k–$410k
- **Posted:** 2026-10-30
- **Last confirmed live:** 2026-11-02
- **Apply:** https://job-boards.greenhouse.io/kiniksapharmaceuticals/jobs/4474876009

## Job description

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

The Group Vice President, Global Regulatory Affairs will provide enterprise-level regulatory leadership across the company’s development and commercial portfolio, shaping global regulatory strategy from early development through approval and lifecycle management.

As the senior leader within the organization, this individual will serve as a strategic advisor to executive leadership and cross-functional development teams, providing regulatory perspective on portfolio strategy, development pathways, regulatory risk, and opportunities to accelerate programs while maintaining the highest standards of scientific and regulatory rigor.

The GVP will lead global regulatory strategy for early- and late-stage biologic programs and approved products, including pivotal Health Authority interactions, global submissions, registrations, and lifecycle strategies. This leader will also bring regulatory insight to the evaluation of new therapeutic opportunities and due diligence, helping inform investment and development decisions across the portfolio.

The individual will lead and further develop the Global Regulatory Affairs organization, including oversight of Global Medical Safety, and will establish strong partnerships across Clinical Development, Medical, Safety, CMC, Commercial, Legal, and other key functions. The role will represent the company with FDA, EMA, and other Health Authorities globally.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week. Significant collaboration will be required with all core functions in the USA and Europe

Responsibilities (including, but not limited to):

Global Regulatory & Portfolio Strategy

- Define and lead U.S. and global regulatory strategies across development-stage and commercial programs, aligning regulatory pathways with clinical development plans and corporate objectives.
- Serve as a senior regulatory advisor to executive leadership, providing clear perspective on regulatory opportunities, precedent, risk, and implications for portfolio and investment decisions.
- Shape regulatory strategy for early- and late-stage development programs, identifying opportunities to accelerate development and optimize pathways to approval.
- Provide regulatory leadership in the evaluation of new therapeutic opportunities, including regulatory due diligence and assessment of development pathways and risks.
- Lead regulatory strategy for approved products, including global registrations, labeling strategy, lifecycle management, and expansion opportunities.

Health Authority Leadership

- Lead the company’s strategy and engagement with FDA, EMA, and other Health Authorities worldwide, including high-impact regulatory interactions, negotiations, and milestone meetings.
- Establish regulatory positions and ensure the organization is prepared to communicate clear, scientifically grounded strategies to global Health Authorities.
- Provide senior leadership for major regulatory submissions, including BLAs, NDAs, MAAs, and significant post-approval filings.

Development & Cross-Functional Leadership

- Serve as the senior regulatory leader across cross-functional development teams, ensuring regulatory strategy is integrated into clinical, CMC, safety, and commercial decision-making.
- Make strategic contributions to clinical development plans, including indication strategy, evidence requirements, endpoint considerations, development sequencing, and registration planning.
- Partner closely with Clinical Development, Medical, Global Medical Safety, CMC, Commercial, Legal, and other functions to drive timely portfolio decisions.

Organizational Leadership

- Lead, develop, and scale a high-performing Global Regulatory Affairs organization capable of supporting the company’s evolving development and commercial portfolio.
- Provide leadership and oversight to the Global Medical Safety function.
- Develop regulatory talent and succession capability while fostering a culture of accountability, collaboration, urgency, and sound judgment.
- Establish and maintain regulatory governance, policies, standards, and operating practices that support organizational growth and inspection readiness.
- Ensure compliance with applicable FDA, EMA, ICH, and global regulatory requirements

Standout Skills for Impact:

Executive Influence Communicates complex regulatory considerations with clarity and conviction, enabling executive leadership and cross-functional teams to make informed decisions around opportunity, risk, and development strategy.

Urgency with Judgment Operates with pace and accountability while maintaining scientific integrity, regulatory compliance, and sound risk-based decision-making.

Builder of High-Performing Teams Creates clear direction, develops talent, and builds an organization capable of operating with both strategic depth and executional excellence.

Qualifications and Experience:

- Advanced degree in a relevant scientific, medical, or pharmaceutical discipline, PhamD/ PhD/ MS
- 15+ years of progressive Regulatory Affairs experience within the biopharmaceutical industry, including significant senior-level regulatory leadership experience.
- Proven track record developing and executing U.S. and global regulatory strategies across multiple stages of drug development.
- Successful leadership of BLA and/or NDA submissions and approvals.
- Extensive experience leading interactions with FDA and other global Health Authorities.
- Deep knowledge of global drug development and regulatory requirements, including FDA, EMA, ICH, and global registration pathways.
- Demonstrated ability to provide strategic regulatory counsel to senior leadership and influence complex cross-functional development and portfolio decisions.
- Proven ability to build, lead, and develop high-performing regulatory teams.
- Preferred experiences: MAA and broader global registration experience. Autoimmune, orphan, and/or expedited development programs, Regulatory CMC strategy and leadership, leveraging AI or emerging technologies within Regulatory Affairs

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range $360,000—$410,000 USD

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.

## About Kiniksa Pharmaceuticals

## Company Overview
- **One-liner**: Kiniksa Pharmaceuticals is a global biopharmaceutical company focused on discovering, developing, and commercializing novel, transformative therapies for patients with significant unmet medical needs, with a primary focus on cardiovascular diseases and immune modulation.
- **Entity Type**: Public (NASDAQ: KNSA)
- **Headquarters**: Lexington, Massachusetts, USA (with additional offices in La Jolla, CA; Zug, Switzerland; and London, UK)
- **Founded**: 2015
- **Founders**: Sanj K. Patel (CEO & Chairman)

## Core Business
- **Primary industry/industries**: Biopharmaceuticals, Biotechnology
- **Target customers**: Patients, healthcare providers, and payers (B2B/B2C model in specialty pharma)
- **Mission or purpose statement**: Dedicated to placing patients first and driving innovation in novel, life-changing therapies to address unmet medical need. The company operates under the belief that "every second makes a difference for patients living with debilitating diseases."

## Products & Services
- **ARCALYST® (rilonacept)**: An FDA-approved treatment for recurrent pericarditis — the first and only FDA-approved therapy for this indication. It is an interleukin-1 alpha and beta cytokine trap.
- **Mavrilimumab**: A clinical-stage anti-GM-CSF receptor alpha monoclonal antibody. A Phase 2 trial in non-mechanically ventilated severe COVID-19 patients yielded positive results. Kiniksa and Huadong Medicine have a collaboration to develop and commercialize it in the Asia Pacific region (excluding Japan).
- **Vixarelimab**: A clinical-stage asset acquired via a global license agreement with Roche and Genentech. It has received FDA Breakthrough Therapy designation for pruritus associated with prurigo nodularis.
- **KPL-404**: A clinical-stage asset for which Kiniksa has initiated a first-in-human study with an antigen challenge (TDAR).

## Market Standing
- **Valuation/Market Cap**: Approximately $1.7 billion (as of mid-2026)
- **Key Metric**: Annual Revenue of $677.6 million (as of mid-2026); Total Funding raised ~$80M in Series A and $170.7M in gross IPO proceeds (2018)
- **Notable Investors/Partners**: Huadong Medicine (Asia Pacific collaboration), Roche, Genentech
- **Growth Signals**: FDA approvals and breakthrough designations, expanding global footprint (UK, Switzerland, Netherlands offices), headcount of 310 employees and growing, active job postings (36 as of mid-2026)

## Competitive Advantages
- **Approved Commercial Product**: ARCALYST® is the first and only FDA-approved therapy for recurrent pericarditis, creating a strong market foothold and revenue stream.
- **Strong Pipeline**: Combination of FDA-approved therapy and clinical-stage assets with strong biologic rationale and validated pathways.
- **Strategic Collaborations**: Partnerships with Roche/Genentech and Huadong Medicine provide access to global markets and cutting-edge science.
- **Leadership**: Led by a team of distinguished life sciences leaders with over 30 years of combined industry experience.

## Strategic Focus
- **Current priorities**: Commercializing ARCALYST® and expanding its indications; advancing the pipeline of clinical-stage assets (mavrilimumab, vixarelimab, KPL-404); expanding global presence (especially in Asia Pacific and Europe); pursuing further strategic acquisitions and collaborations.
- **Patient-centric innovation**: Focus on immune modulation targeting unmet needs and underserved conditions.

## Why Work Here
- **Culture**: Fosters a culture of passion, innovation, and rapid execution. Employees are described as "highly skilled, driven people advancing their careers—and making a difference in patients' lives."
- **Commitment to employees**: Kiniksa is intentional about cultivating a highly skilled and passionate team determined to deliver on its promise to patients.
- **Work environment**: Global company with offices in the US (Lexington, MA; La Jolla, CA), Switzerland (Zug), and the UK (London). The company offers a collaborative, science-driven environment.
- **Diversity, Equity, and Inclusion**: Committed to creating a culture of equality that celebrates diversity and fosters innovation; an Equal Opportunity Employer.
- **Perks & Benefits (US)**:
    - **Healthcare & Well-being**: Robust PPO medical insurance (Blue Cross Blue Shield) with HRA to cover deductible; dental (including orthodontia); vision; flexible spending accounts; fertility benefits and parental leave (up to 10 weeks at 100% pay, plus 6-8 weeks disability for birth parents); behavioral health support via EAP; and mental health programs.
    - **Financial & Protection**: 401k with traditional and Roth options through Fidelity, with immediate company match; Employee Stock Purchase Plan (15% discount); employer-paid life and AD&D insurance; short- and long-term disability coverage; voluntary additional life insurance.
    - **Work-Life Balance**: Paid sick and vacation time; company-paid holidays; company-sponsored events and volunteer opportunities.
    - **Other**: Subsidized lunches; employee referral program; starting coverage on the first day of employment.

## Sources
1. [Kiniksa Pharmaceuticals - About Us](https://www.kiniksa.com/about)
2. [Kiniksa Pharmaceuticals - Join Us](https://www.kiniksa.com/join-us)
3. [Kiniksa Pharmaceuticals - Leadership](https://www.kiniksa.com/leadership)
4. [Kiniksa Pharmaceuticals - LinkedIn Company Page](https://www.linkedin.com/company/kiniksa-pharmaceuticals)
5. [Kiniksa Pharmaceuticals - Main Site](https://www.kiniksa.com/)

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