New · posted Oct 31
Kiniksa Pharmaceuticals International · Pharmaceuticals
GVP, Global Regulatory Affairs
- Lexington, MA
- On-site
- Full-time
- VP & Executive
The role
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
What you need
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
$360,000 – $410,000 a year
Employer provided$360,000—$410,000 USD
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesKiniksa Pharmaceuticals International's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 19% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
VP & Executive roles in Massachusetts7 roles publishing pay
VP & Executive roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $360,000 | — | $410,000 |
| Massachusetts (middle half) | $290,750 | $313,000 | $328,750 |
| All US (middle half) | $307,375 | $322,750 | $362,375 |
This role: Kiniksa Pharmaceuticals International's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 303 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Kiniksa Pharmaceuticals's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership24
- Regulatory submissions11
- Clinical trial conduct4
- GMP and compliance3
- Documentation and SOPs1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Kiniksa Pharmaceuticals on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Clinical4 50%
- Regulatory2 25%
- Quality2 25%
By level
- Director5 63%
- VP & Executive1 13%
- Manager1 13%
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GVP, Global Regulatory Affairs at Kiniksa Pharmaceuticals
Open until filled. $360K–$410K a year, employer provided.