Assoc. Director, Regulatory Affairs

Kiniksa Pharmaceuticals•Lexington, MA

10h•$195,000 - $210,000•Hybrid

About The Position

Reporting to the Exec. Dir, Reg Affairs Strategy Clinical/Technical Writing, the Associate Director, Regulatory Affairs will support and drive the execution of key regulatory activities across Kiniksa’s development programs. This role is operationally focused and responsible for coordinating, preparing, and managing high quality regulatory submissions, maintaining compliance, and supporting interactions with global health authorities. The ideal candidate excels at navigating the day to day regulatory process, thrives in a fast paced environment, and demonstrates strong ownership of submission deliverables. Experience supporting combination products is a plus. This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Requirements

Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
8+ years of experience in Regulatory Affairs within the biopharmaceutical industry.
Proven experience managing regulatory submissions and supporting health authority interactions.
Solid working knowledge of US and ex-US regulatory requirements and submission formats.
Strong project management, organizational, and communication skills.
Comfortable managing multiple concurrent submissions and deadlines.
Familiarity with eCTD and electronic publishing workflows.
Hands-on experience with late-stage or post marketing regulatory obligations.

Nice To Haves

Experience supporting combination products (drug–device or biologic–device) is a plus.
Experience in immunology, rare disease, or biologics programs.
Experience working directly with clinical and technical writers.

Responsibilities

Lead the planning, coordination, authoring, and assembly of regulatory submissions including INDs/CTAs, amendments, safety reports, annual reports, and marketing application components.
Work closely with Clinical Technical Writing to ensure accuracy, consistency, and timely delivery of submission-ready documents.
Manage submission timelines, deliverable tracking, and cross-functional coordination to ensure on-time submissions.
Collaborate with Regulatory Operations to ensure submissions meet formatting, technical, and quality standards.
Support preparation for regulatory interactions, including drafting and coordinating meeting requests, information packages, and responses to questions.
Compile and organize documentation for health authority meetings, ensuring internal teams are well-prepared.
Maintain accurate records of regulatory correspondence and commitments, ensuring follow-through and compliance.
Ensure adherence to global regulatory requirements, internal procedures, and industry standards.
Maintain regulatory documentation, tracking tools, and compliance systems to support inspection-readiness.
Monitor submission status, health authority feedback, and timelines, ensuring prompt follow-up actions.
Serve as the day-to-day regulatory point of contact for specific programs.
Partner with Clinical, CMC, Nonclinical, Pharmacovigilance, and Technical Writing teams to gather data, resolve issues, and ensure submission readiness.
Provide practical regulatory guidance on document expectations, timelines, and operational requirements.