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Senior Manager Regulatory Affairs

Syncromune

Role overview

Qualifications

  • Bachelor’s Degree in Life Sciences, Engineering or related field
  • 5+ years in a regulatory capacity at a pharmaceutical company, biotech or CRO
  • High degree of understanding of regulatory requirements
  • Excellent organizational and project management skills

Responsibilities

  • Assist in all facets of the company’s Regulatory Affairs for U.S. and international regulatory matters
  • Support the Senior Director of Regulatory Affairs to ensure adherence to regulations and standards
  • Prepare regulatory submissions for combination products, drugs, and medical devices
  • Anticipate and mitigate regulatory risks and identify opportunities for regulatory flexibility

Key facts

Hard skills

Risk Analysis Project Management Technical Writing Standard Operating Procedure Database Software Expedited Funds Availability Act Compliance Management

Other skills

  • Microsoft Office
  • Communication
  • Collaboration
  • Detail Oriented
  • Problem Solving
  • Analytical Skills

About the company

Syncromune logo

Syncromune

Biotechnology

LEGION-100 Trial for Metastatic Prostate Cancer is Now Enrolling - Learn More: www.legion100trial.com Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class cancer immunotherapy platform designed to address major unmet needs and treatment challenges of incurable metastatic solid tumors. 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: tumor antigens, immune cells, and our multi-target biologic drug. SYNC-T features a novel proprietary device delivery system that is optimized for combination drug/device immunotherapy. First, the system lyses a portion of a target tumor to rupture tumor cells and release a heterogeneous population of tumor antigens into the tumor microenvironment (TME) that may help the immune system recognize cancer. Next, the delivery system facilitates the infusion of our proprietary multi-target immunomodulatory drug directly into the tumor in the zone that was lysed. The volume of the infusion promotes flow of the tumor antigens and drug into tumor-draining lymph nodes where they synchronize location with immune cells, aiming to create conditions for T cell activation. 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 empower the immune system to recognize and attack both the primary cancer and metastatic lesions throughout the body and defend with immune memory. Our investigational lead candidate, SYNC-T Therapy SV-102 is being evaluated for metastatic castration-resistant prostate cancer (mCRPC), in LEGION-100, a U.S., multicenter, Phase 2 trial. For more information, please visit www.legion100trial.com.

Company details

IndustryBiotechnology
Company size51 - 200

Links

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Job description

The Senior Manager of Regulatory Affairs will assist in all facets of the company’s Regulatory Affairs for all U.S. and international regulatory matters, including filings and interactions with regulatory authorities.

Principal Duties and Responsibilities include the following:
The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.
  • Support the Senior Director of Regulatory Affairs to ensure adherence to appropriate regulations and standards.
  • Assists with determining regulatory requirements and prepare regulatory submission for all new/modified combination products, drugs, and medical devices. These submissions can include but not be limited to IND’s, BLA’s, meeting packages and expediated programs.
  • Provide strategic input on development plans and sequencing of regulatory submissions (participate in the coordination, preparation and timely submission of regulatory documents).
  • Anticipate and mitigate regulatory risks; proactively identify opportunities for regulatory flexibility, expedited programs, and innovative pathways.
  • Partner closely 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/registrations and responses 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 (SOPs).
  • Ensure regulatory documentation is maintained appropriately.
  • Interact with regulatory agencies as required.
  • Contribute to the evolution of regulatory strategy capabilities, regulatory internal processes, and best practices within the organization.
  • Promote a culture of scientific rigor, regulatory strategy excellence, and proactive risk evaluation.
 Supervisory Responsibilities:
  • None
Qualification Requirements:
Education:
  • Bachelor’s Degree in Life Sciences, Engineering or related field
  • Master’s degree preferred
Experience:
  • 5+ years in a regulatory capacity at a pharmaceutical company, biotech or CRO with 2+ years supporting oncology products.
  • High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them
  • Experience in authoring part of regulatory documents such as M1, M2 of an IND, IND amendments, response to regulatory agency’s IR, expediated program applications.
  • Ability to inform and educate managers and department heads on regulations and policies that require compliance
  • Ability to translate regulatory requirements into practical, workable plans
  • Proficient with Microsoft Office Suite or similar software
  • Proficient with applicable database and compliance software
  • Must be able to juggle multiple and competing priorities
Knowledge/Skill:
  • Excellent organizational and project management skills.
  • Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
  • Excellent attention to detail.
  • Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
  • Ability to work in a fast-paced virtual environment.
  • Excellent verbal and writing skills.
  • Excellent analytical and problem-solving skills
  • Excellent editing and proof-reading skills.
  • Possess a self-directing, self-starting work ethic.
  • Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines.
Working Conditions:
  • The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL.
  • Domestic travel up to 10% of time
  • Ability to lift up to 25 pounds
  • Regularly required to stand, sit, talk, hear, and use hands
  • Prolonged periods of sitting and standing         
Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:  $160,000-180,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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