Kiniksa Pharmaceuticals · 6 days ago
Senior Director, Regulatory Affairs CMC
Lexington, MA
Full-time
Hybrid
Director/Executive
$278K/yr - $295K/yr
10+ years expKiniksa Pharmaceuticals is seeking a Senior Director of Regulatory Affairs CMC to develop and implement regulatory strategies for unique products aimed at meeting unmet medical needs. The role involves providing regulatory leadership, ensuring effective communication with health authorities, and managing CMC documents for regulatory submissions.
BiopharmaBiotechnologyMedical
Responsibilities
Provide regulatory CMC strategic leadership for drug development projects and life cycle management, including but not limited, to health authority interactions, regulatory submissions and other regulatory requirements in line with corporate objectives and timelines
Serve as a well-respected spokesperson with staff at FDA and other Health Authorities to present and negotiate on CMC issues
Provide de-risking CMC development strategies, assessing change controls and evaluating opportunities to accelerate development in a fast-paced environment
Provide leadership, and contribute hands on support to the regulatory and manufacturing team in managing, planning, coordinating, and preparing all CMC documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTRs/IMPDs, amendments, and annual updates
Interpret and communicate regulatory CMC expectations to internal and external stakeholders in order 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
Qualification
Required
Requires a Master's Degree (PharmD)
10+ years of experience in regulatory affairs within the bio pharmaceutical industry
Strong knowledge of FDA regulations and EU CTA/CTR requirements
Experience with preparing CMC regulatory documents including new INDs, IND amendments, annual reports, briefing packages and other regulatory submissions required
Strong leadership and communication skills and experience in working with multiple functional areas in a matrixed team environment required
Strategic thinker who can balance near term objectives with long term goals and outcomes
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
Preferred
PhD preferred
Prior experience with biologics drug development/monoclonal antibodies is strongly desired
Prior experience and success with filing original BLAs/MAAs desired
Experience with both early and late-stage drug development, and life cycle management desired
Experience with tech transfers/manufacturing transfers desired
Experience interacting directly with the FDA and other health authorities desired
Company
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals is developing therapies for inflammatory and autoimmune conditions.
201-500 employees
H1B Sponsorship
Kiniksa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (3)
2022 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Baker Brothers Advisors LLC
2020-05-13Post Ipo Equity· $80M
2018-05-23IPO
2018-02-01Series C· $200M
Leadership Team
Eben Tessari
Chief Operating Officer
Aaron Young
Senior Vice President, Chief Intellectual Property Officer
Recent News
GlobeNewswire
2026-01-13
2025-12-09
2025-10-29
Company data provided by crunchbase