Full-Time

Senior Manager Regulatory Affairs

Posted on 8/21/2026

Syncromune

Syncromune

51-200 employees

Develops intratumoral immunotherapies for cancer

Compensation Overview

$160k - $180k/yr

+ Cash incentive compensation + Equity incentive compensation

Remote in USA

Hybrid

Virtual work is split with the company headquarters in Fort Lauderdale, Florida; domestic travel up to 10% is required.

Bachelor's, Master's

Category
Legal & Compliance (1)
Required Skills
Microsoft Office

Get referred to Syncromune

See people who can refer or advise you

Requirements
  • Bachelor’s degree in Life Sciences, Engineering, or a related field.
  • At least 5 years of experience in a regulatory capacity at a pharmaceutical company, biotech company, or contract research organization, including at least 2 years supporting oncology products.
  • A high degree of understanding of regulatory requirements, how they operate, how to obtain updated information, and where to obtain interpretations of them.
  • Experience authoring portions of regulatory documents such as M1 and M2 of an Investigational New Drug application, Investigational New Drug amendments, responses to regulatory agency information requests, and expedited program applications.
  • Ability to inform and educate managers and department heads on regulations and policies requiring compliance.
  • Ability to translate regulatory requirements into practical, workable plans.
  • Proficiency with Microsoft Office Suite or similar software.
  • Proficiency with applicable database and compliance software.
  • Ability to manage multiple competing priorities.
  • Excellent organizational and project management skills.
  • Ability to work on multiple projects simultaneously and take on new challenges as needed.
  • Excellent attention to detail.
  • Outstanding communication and collaboration skills within cross-functional teams and external organizations.
  • Excellent verbal and writing skills.
  • Excellent analytical and problem-solving skills.
  • Excellent editing and proofreading skills.
  • Self-directing and self-starting work ethic.
  • Excellent knowledge of the competitive environment for oncology drugs and research and development pipelines.
Responsibilities
  • Support the Senior Director of Regulatory Affairs in ensuring adherence to appropriate regulations and standards.
  • Determine regulatory requirements and prepare regulatory submissions for new or modified combination products, drugs, and medical devices, including Investigational New Drug applications, Biologics License Applications, meeting packages, and expedited programs.
  • Provide strategic input on development plans and sequencing of regulatory submissions, including coordinating, preparing, and submitting regulatory documents on time.
  • Anticipate and mitigate regulatory risks and identify opportunities for regulatory flexibility, expedited programs, and innovative pathways.
  • Partner with cross-functional teams and influence program decision-making by integrating regulatory considerations early and consistently.
  • Ensure project teams prepare high-quality international and domestic filings and registrations and respond to agency requests within established timelines.
  • Review submission packages for compliance with global regulations.
  • Write and edit technical documents.
  • Review and create standard operating procedures.
  • Ensure regulatory documentation is maintained appropriately.
  • Interact with regulatory agencies as required.
  • Contribute to the evolution of regulatory strategy capabilities, internal regulatory processes, and organizational best practices.
  • Promote scientific rigor, regulatory strategy excellence, and proactive risk evaluation.
Desired Qualifications
  • Master’s degree.

What Syncromune does: Develops intratumoral immunotherapies to treat metastatic cancers by delivering immune-stimulating agents directly into tumors, prompting the body's immune system to attack cancer cells. How the product works: Therapies are injected or delivered into the tumor site, activating local immune responses and enabling systemic anti-tumor activity against metastatic lesions, backed by R&D and clinical trials. How it differs from competitors: Focused intratumoral approach and pipeline aimed at leveraging the tumor microenvironment to awaken immune responses, with a strategy combining direct tumor delivery, clinical validation, and partnerships for commercialization rather than broad systemic immunotherapies. What the goal is: To advance research and development, complete clinical trials, and achieve commercialization of proprietary treatments while pursuing long-term, sustained growth to improve outcomes for patients with advanced cancers.

Company Size

51-200

Company Stage

Series A

Total Funding

$115.3M

Headquarters

Fort Lauderdale, Florida

Founded

2020

Get referred to Syncromune

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • Syncromune says LEGION-100 was enrolling on June 17, 2026, widening clinical exposure.
  • April 29, 2026 data showed 87% ORR and no grade 4/5 toxicities.
  • Dr. Stephen Dale joined January 6, 2026, strengthening clinical execution and regulatory credibility.

What critics are saying

  • LEGION-100 remains a single-program bet; one Phase 2 failure threatens Syncromune’s existence.
  • Phase 2 readout risk stays high because 15-patient Phase 1 data is non-randomized.
  • Combination drug-device manufacturing and site adoption complicate enrollment, timeline, and reimbursement after 2026.

What makes Syncromune unique

  • SYNC-T combines freeze-thaw tumor lysis, intratumoral biologic infusion, and lymph-node delivery.
  • LEGION-100 targets mCRPC with a proprietary drug-device platform, not systemic checkpoint therapy.
  • Gustave Roussy and MD Anderson featured Syncromune at the first intratumoral symposium, June 2026.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Company Equity

Remote Work Options

Hybrid Work Options

Growth & Insights and Company News

Headcount

6 month growth

1%

1 year growth

-1%

2 year growth

1%
Syncromune
Jun 17th, 2026
Syncromune(R) presents multi-modal efficacy assessment framework at inaugural Gustave Roussy Intratumoral Immunotherapy Symposium.

Syncromune(R) presents multi-modal efficacy assessment framework at inaugural Gustave Roussy Intratumoral Immunotherapy Symposium. FORT LAUDERDALE, Fla. and WEST DES MOINES, Iowa, June 16, 2026 (GLOBE NEWSWIRE) - Syncromune, Inc., a privately held clinical-stage biopharmaceutical company developing SYNC-T(TM), an investigational in situ multi-target immunotherapy platform for solid tumors, today announced that Executive Chairman and Chief Innovation Officer Charles Link, M.D., presented and served as a panelist at the inaugural Intratumoral Immunotherapy Symposium 2026. The event was hosted by Gustave Roussy in partnership with MD Anderson Cancer Center on June 11-12, 2026, in Villejuif, Paris, France. Dr. Link's presentation highlighted the growing need for a multi-modal, immune-aware framework to better assess efficacy in intratumoral immunotherapy. He addressed a key challenge in the field: while these therapies are delivered locally, they are designed to elicit systemic anti-tumor responses. Importantly, this often manifests as an abscopal effect observed both with ipsilateral and contra-lateral cancer regression distally. Conventional response criteria alone often fail to fully capture their activity due to delayed or non-linear response patterns and inflammatory changes that can mimic disease progression. His talk emphasized the value of integrating complementary readouts from imaging and other clinical measures to provide a more comprehensive evaluation of treatment effects over time. "It was an honor to be invited to present at the inaugural Gustave Roussy Intratumoral Immunotherapy Symposium, which brought together many of the world leaders helping define this emerging field," said Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune, and Adjunct Professor at the Lankenau Institute for Medical Research. "Intratumoral immunotherapies hold significant promise, as they are designed to generate potent systemic anti-tumor activity while potentially limiting systemic drug exposure and toxicity. The local delivery approach with systemic therapeutic intent also requires a more dynamic, immune-aware paradigm for assessing efficacy. We believe the framework presented at the symposium will help support the clinical development and broader adoption of intratumoral immunotherapy for patients who need it most." Dr. Link also participated in the panel discussion on "Cross-Sector Collaboration," which brought together leaders from academia, biotechnology, interventional oncology, and regulatory science to explore how strategic partnerships can accelerate the development, clinical translation, and adoption of intratumoral immunotherapies. The two-day international symposium was the first event fully dedicated to intratumoral immunotherapy. The program featured discussions on next-generation agents, image-guided and minimally invasive delivery technologies, patient and lesion selection based on tumor biology and imaging, response monitoring using CT, MRI, bone scans, PSMA PET, and other biomarkers, lessons from late-stage trials, regulatory considerations, and best practices in trial design. A central focus was fostering cross-sector dialogue to advance the field. "Our experience in metastatic prostate cancer has underscored the importance of evaluating intratumoral immunotherapies in a way that reflects the unique biology and response kinetics of this therapeutic approach," said Stephen Dale, M.D., Chief Medical Officer of Syncromune. "The insights generated from our Phase 1 study are already helping inform assessment strategies in our ongoing LEGION-100 trial, and we believe this type of translational learning will be critical to advancing the field." About Syncromune(R) and SYNC-T(TM) Therapy Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet medical needs and treatment challenges of metastatic solid tumor cancers. SYNC-T is an investigational in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response. The platform features a novel proprietary needle-base device delivery system that is optimized for combination drug/device immunotherapy. First, the system is designed to lyse a portion of a target tumor via a proprietary freeze/thaw method to rupture tumor cells and release patient-specific tumor antigens into the tumor microenvironment (TME) which helps activate the immune system. Next, the delivery system facilitates the infusion of its investigational multi-target immunomodulatory drug directly into the lysed area of the tumor. The volume of the infusion is intended to promote the flow of antigens and the drug into tumor draining lymph nodes where they synchronize location with immune cells. This co-localization approach is designed to unite the three critical components needed to create conditions for T cell activation. The combination intratumoral therapy is designed to target numerous mechanisms of cancer, potentially promoting in situ immune activation while battling immune suppression and minimizing systemic drug exposure. The goal is to generate a systemic anti-tumor response that can recognize and attack both primary and metastatic tumors throughout the body and support immune memory. Its lead candidate, SYNC-T Therapy SV-102, is currently being evaluated in the U.S. in its multicenter, Phase 2a LEGION-100 clinical trial for metastatic castration-resistant prostate cancer (mCRPC). For more information, please visit www.legion100trial.com. This press release includes forward-looking statements concerning its business, operations and financial performance and condition, as well as its plans, objectives and expectations for its business operations and financial performance and condition. Any statements contained in this press release or expressed orally in connection herewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified by phrases such as "plans," "intends," "believes," "expects," "anticipates," "foresees," "forecasts," "estimates" or other words or phrases of similar import. Similarly, statements herein that describe its business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Accordingly, you should not place undue reliance on its forward-looking statements. The forward-looking statements contained in this press release or expressed orally in connection herewith are made only as of the date of this press release and Syncromune, Inc. undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law. This press release was prepared by Syncromune, Inc. for informational purposes only and does not constitute an offer, or solicitation of an offer, to sell any securities at any time. None of Syncromune's securities have been registered under the Securities Act of 1933, as amended, or any state securities law. Such securities have not been approved or disapproved by the Securities and Exchange Commission or by any state securities regulatory authority, nor has the Securities and Exchange Commission or any such state authority passed on the accuracy or adequacy of this press release. Any representation to the contrary is a criminal offense. Some of the information contained in this press release may be derived from information provided by industry sources. Syncromune, Inc. believe that such information is accurate and that the sources from which it has been obtained are reliable; however, Syncromune, Inc. cannot guarantee the accuracy of such information and have not independently verified such information. Danielle Hobbs EVP, Marketing & Commercial Strategy [email protected] About Syncromune Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet needs and treatment challenges of incurable metastatic solid tumor cancers. SYNC-T is an in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response: patient-specific tumor antigens, immune cells, and its multi-target biologic drug. SYNC-T features a novel proprietary device delivery system that is optimized for combination drug/device immunotherapy. The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to activate T cells, empowering the immune system to recognize and attack the patient's cancer throughout the body and defend with immune memory. Its lead candidate, SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer (mCRPC), is being evaluated in a U.S., multicenter, Phase 2 trial. For more information, please visit www.legion100trial.com. *Please note the translation function may not be accurate for every dialect

The Manila Times
Jan 6th, 2026
Syncromune Continues to Strengthen Executive and Clinical Leadership with Appointment of Dr. Stephen P. Dale, M.D., as Chief Medical Officer

Syncromune continues to strengthen Executive and clinical leadership with appointment of Dr. Stephen P. Dale, M.D., as Chief Medical Officer. FORT LAUDERDALE, Fla. and WEST DES MOINES, Iowa, Jan. 06, 2026 (GLOBE NEWSWIRE) - Syncromune(R) Inc., a clinical-stage biopharmaceutical company dedicated to the development of SYNC-T(TM), an in situ platform combination immunotherapy optimized for solid tumor cancers, today announced the appointment of Stephen P. Dale, M.D., as Chief Medical Officer. "Our priority at Syncromune is to develop therapies that meaningfully improve the lives of patients facing some of the most challenging cancers," said Chuck Link, M.D., Adjunct Professor at the Lankenau Institute for Medical Research (LIMR) and Co-Founder and Executive Chairman at Syncromune. "By combining Dr. Dale's physician perspective and patient-focused approach to clinical development, we will ensure our programs prioritize safety and impact as we advance our clinical objectives." Dr. Dale brings more than 20 years of global oncology research and development (R&D) leadership to Syncromune, with deep experience across both biotechnology and large pharmaceutical organizations. He has led early- and late-stage clinical development and translational strategy efforts, contributing to multiple regulatory approvals. His expertise includes guiding programs through pivotal trial design, first-in-class dose optimization, and IND-enabling studies in alignment with evolving FDA and EMA guidance. Prior to joining Syncromune, Dr. Dale served as Head of R&D and Chief Medical Officer at Kura Oncology. He previously held senior oncology R&D and clinical leadership roles at Kyowa Kirin and AstraZeneca, where he led global development programs across solid and hematological tumors, immuno-oncology, precision oncology, and rare diseases. He obtained his Doctor of Medicine and MBChB degrees from the University of Manchester Medical School. As Chief Medical Officer of Syncromune, Dr. Dale will lead the clinical development of SYNC-T, provide strategic and medical oversight for the company's expanding pipeline, and play a central role in shaping Syncromune's clinical, regulatory, and translational roadmap moving forward. Eamonn Hobbs, Co-Founder, President, and Chief Executive Officer of Syncromune added, "Dr. Dale's oncology experience and proven leadership in advancing innovative therapies through clinical development make him an exceptional addition to our team. His expertise will be invaluable as we progress SYNC-T Therapy SV-102 through Phase 2 and broaden the platform's potential across solid tumors. We are thrilled to welcome him at this important stage of Syncromune's growth." "I'm honored to join Syncromune at this pivotal juncture in its evolution," said Dr. Dale. "Syncromune's vision to deliver multi-target immunotherapies that activate the immune system locally while minimizing systemic exposure and toxicity reflects the patient-centered innovation that has guided my career. I'm eager to partner with the team to accelerate therapies that offer new possibilities for patients with few or no effective treatment options." About Syncromune(R) and SYNC-T(TM) Therapy Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet medical needs and treatment challenges of metastatic solid tumor cancers. SYNC-T is an in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response. SYNC-T features a novel proprietary needle-like device delivery system that is optimized for combination drug/device immunotherapy. First, the system lyses a portion of a target tumor via a proprietary freeze/thaw method to rupture tumor cells and release patient-specific tumor antigens into the tumor microenvironment (TME) that helps to activate the immune system. Next, the delivery system facilitates the infusion of our proprietary multi-target biologic drug directly into the lysed area of the tumor. This approach of location synchronization is designed to unite the three critical components of patient-specific tumor antigens, immune cells, and our multi-target biologic drug together in the draining lymphatics where the immune system optimally functions. The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to educate the immune system and activate T cells that can recognize and attack cancer throughout the body and defend with immune memory. Our lead candidate, SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer (mCRPC), is being evaluated in the LEGION-100 U.S., multicenter, Phase 2 trial. For more information, please visit www.legion100trial.com. This press release includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained in this press release or expressed orally in connection herewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified by phrases such as "plans," "intends," "believes," "expects," "anticipates," "foresees," "forecasts," "estimates" or other words or phrases of similar import. Similarly, statements herein that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Accordingly, you should not place undue reliance on our forward-looking statements. The forward-looking statements contained in this press release or expressed orally in connection herewith are made only as of the date of this press release and we undertake no obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law. None of Syncromune, Inc., its affiliates or their respective directors, officers, employees or agents gives any representation or warranty, express or implied, as to: (i) the achievement or reasonableness of future projections, management targets, estimates or prospects contained in this press release; or (ii) the accuracy or completeness of any information contained in this press release, any other written information or oral information provided in connection herewith or any data that any of them generates. This press release was prepared by us for informational purposes only and does not constitute an offer, or solicitation of an offer, to sell any securities at any time. None of Syncromune's securities have been registered under the Securities Act of 1933, as amended, or any state securities law. Such securities have not been approved or disapproved by the Securities and Exchange Commission or by any state securities regulatory authority, nor has the Securities and Exchange Commission or any such state authority passed on the accuracy or adequacy of this press release. Any representation to the contrary is a criminal offense. Some of the information contained in this press release may be derived from information provided by industry sources. We believe that such information is accurate and that the sources from which it has been obtained are reliable; however, we cannot guarantee the accuracy of such information and have not independently verified such information.

The Manila Times
Jun 16th, 2025
Syncromune(R) Appoints Industry Veteran Kerri-Ann Millar as Chief Financial Officer to Advance Corporate Growth Initiatives and Clinical Development Program

Syncromune(R) appoints industry veteran Kerri-Ann Millar as Chief Financial Officer to advance Corporate growth initiatives and clinical development program.

The Pharma Letter
Mar 25th, 2025
Syncromune appoints Zhihong Li as head of regulatory affairs

US clinical-stage biotech Syncromune today announced the appointment of Zhihong Li as chief regulatory affairs officer.

Endpoints News
Dec 20th, 2024
Exclusive: Florida cancer biotech raises $100M Series A

Syncromune, a biotech startup working on combination immunotherapies, has put together a $100 million Series A, the company told Endpoints News.