Director/Sr. Director/Executive Director, Clinical Regulatory Affairs jobs in United States
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SystImmune · 1 month ago

Director/Sr. Director/Executive Director, Clinical Regulatory Affairs

positionPrinceton, NJ, US
timeFull-time
remoteOnsite
seniorityDirector/Executive

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments. The Regulatory Affairs role will drive regulatory strategy and execution for global regulatory affairs related to oncology therapeutics, focusing on compliance with global health authority regulations.

BiopharmaBiotechnologyProfessional Services

Responsibilities

Integrate scientific, medical and regulatory perspectives to drive development of innovative global regulatory strategies to achieve rapid approvals for investigational and marketing plans from agencies such as FDA, EMA, PMDA, NMPA (CHN)
Perform research to drive development of regulatory strategy for the assigned clinical development program
Lead and drive the preparation for Agency meetings and associated briefing document preparation
Lead and manage queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Lead representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Maintain knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
Exercise discretion, demonstrate integrity and independent judgment in the performance of the duties described above

Qualification

Oncology regulatory experienceGlobal regulatory strategyBLA/IND submissionsCollaboration with agenciesRegulatory compliance knowledgeData-informed decision makingLeadershipAttention to detail

Required

Demonstrated expertise in Oncology regulatory experience
Global regulatory agency experiences including successful BLA/MAA filings
Experience with label negotiations
Prior experience of working across partner companies in a collaborative setting
Leadership skills
Attention to detail
Ability to drive data-informed decision making in a fast-paced setting
Ability to toggle between 'player/coach roles' as needed

Company

SystImmune

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SystImmune is a biotechnology company.
dateFounded in 2014
location
Redmond, Washington, USA
people-size51-200 employees
web-link
https://www.systimmune.com

Funding

Current Stage
Growth Stage

Leadership Team

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Martin S. Olivo, MD, MSc,
Chief Medical Officer
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Recent News

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Global Launch Event for iza-bren Phase III Nasopharyngeal Carcinoma Research Results Successfully Held, Streamed on ESMO Official Website
2025-10-24
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ADC, Bispecifics and Kinase Blockers Steal the Spotlight at ESMO 2025 in Berlin
2025-10-23
PR Newswire
SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren, an EGFR x HER3 Bispecific Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors at ESMO 2025
2025-10-17
Company data provided by crunchbase