New · posted Nov 14
Kiniksa Pharmaceuticals International · Pharmaceuticals
Director, Regulatory Affairs Labeling
- Lexington, MA
- On-site
- Full-time
- Director
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.
Reporting to the Executive Director, Regulatory Affairs AdPromo and Labeling, the Director, Regulatory Affairs Labeling, will be responsible for all labeling activities for approved products, as well as products in development that are nearing original submissions to the FDA and other health authorities. This role will also serve on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC) for assigned activities. This individual will provide timely input to cross-functional teams responsible for reviewing labeling and promotional materials for Kiniksa’s products and will ensure effective communication with business partners and regulatory authorities.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
What you need
Standout Skills for Impact
- Experienced regulatory professional who can provide guidance and influence negotiations and outcomes within the Labeling Working Group and Promotional Review Committee. Expert knowledge of FDA labeling, advertising, and promotion regulations and guidelines.
- Expert understanding of FDA labeling regulations and guidelines, with responsibility for establishing and overseeing the labeling function at Kiniksa.
- Demonstrated ability to influence others and foster team collaboration
Qualifications and Experience
- BA/BS degree and a minimum of 8-10 years of pharmaceutical or biopharmaceutical industry experience, including at least 5 years of regulatory affairs experience focused on reviewing advertising and promotion materials for prescription drug and/or biologic products.
- Prior experience and success in launching new products or additional indications.
- Strong leadership and communication skills, with experience working across multiple functional areas in a matrixed team environment.
- Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience
- Ability to thrive in a collaborative and fast-paced team environment
- Experience communicating and negotiating directly with FDA.
- Expert understanding of FDA advertising and promotion regulations and guidelines specific to pharmaceutical and biopharmaceutical products.
- Expert understanding of FDA labeling regulations and guidelines
- Experience writing labeling documents (USPI, Instructions for Use, SmPC, etc.).
- Strong interpersonal, oral, and written communication skills.
- Demonstrated ability to influence others and foster team collaboration
- Strong verbal and written communication skills
- High level of initiative and commitment
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
What you'll do
Responsibilities (including, but not limited to)
- Lead cross-functional teams in the development and maintenance of labeling content, including USPI, SmPC, IFU, PPI, and CDS.
- Manage labeling development, review, and approval workflows, including related meetings, documents, and labeling change controls.
- Maintain labeling expertise regarding U.S. requirements and stay current with labeling guidelines and regulations from the FDA, EMA, and other applicable authorities, as needed.
- Serve as the regulatory representative on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC) for assigned activities.
- Be responsible for regulatory submissions of labeling and promotional materials to the FDA.
- Provide insight, sound judgment, and clear direction to Commercial and Medical teams during the development, review, and approval of product labeling, advertising and promotion materials, and disease awareness campaigns.
- Identify and provide guidance on the development and improvement of policies, processes, and standards for promotional materials and related activities.
- Maintain regulatory expertise in product promotion compliance by staying current with FDA enforcement actions and monitoring trends.
- Take a hands-on approach while also setting strategy.
- Provide risk assessments of promotional campaigns in a fast-paced environment.
- Interpret and communicate regulatory expectations to internal and external stakeholders to execute program objectives in compliance with applicable regulations.
- Contribute to the strategic leadership and development of policies, procedures, and best practices commensurate with the requirements of a rapidly growing company.
Pay
$216,000 – $232,000 a year
Employer provided$216,000—$232,000 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 · November 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% above the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $216,000 | — | $232,000 |
| Massachusetts (middle half) | $198,500 | $201,000 | $205,500 |
| All US (middle half) | $198,500 | $205,500 | $223,000 |
This role: Kiniksa Pharmaceuticals International's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 81 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not Kiniksa Pharmaceuticals's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership15
- Regulatory submissions10
- GMP and compliance7
- Documentation and SOPs3
- Quality systems and risk2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Labeling & Promotion work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDA21 CFR Part 202(official source, opens in a new tab)Prescription drug advertising: fair balance and required information
- FDAFDA OPDP(official source, opens in a new tab)The Office of Prescription Drug Promotion, which reviews advertising and promotion
- FDAFDA prescription drug labeling resources(official source, opens in a new tab)Physician Labeling Rule (PLR) format and content of prescribing information
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Structured Product Labeling(official source, opens in a new tab)The SPL standard for submitting labeling content to FDA
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDAFDA REMS(official source, opens in a new tab)Risk Evaluation and Mitigation Strategies for drugs with serious safety concerns
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- CMSOpen Payments (Sunshine Act)(official source, opens in a new tab)Reporting of manufacturer payments to physicians and teaching hospitals
- HHS-OIGHHS-OIG General Compliance Program Guidance(official source, opens in a new tab)The federal government's guide to healthcare compliance programs and the anti-kickback statute
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Kiniksa Pharmaceuticals on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Regulatory3 38%
- Clinical3 38%
- Quality2 25%
By level
- Director5 63%
- VP & Executive1 13%
- Manager1 13%
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Director, Regulatory Affairs Labeling at Kiniksa Pharmaceuticals
Open until filled. $216K–$232K a year, employer provided.