• Director of Regulatory Affairs

    Job ID
    2018-1129
    Category
    Regulatory Affairs/Quality Assurance
    Job Location
    US-MA-Cambridge
  • Company Summary

    Jounce Therapeutics, Inc. is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in a Phase 1/2 trial. For more information, please visit http://jouncetx.com/

     

    We have many career opportunities at Jounce and are looking for exceptional individuals who share our passion and perseverance for developing highly durable cancer immunotherapies that can dramatically impact and improve patients’ lives.

    Role / Responsibilities

    The Regulatory Affairs (RA) Director will serve as the global regulatory lead for assigned programs for Jounce Therapeutics, Inc. This role requires expert interpretation of requirements relating to the development and licensing of biopharmaceuticals and communication to cross-functional teams to create innovative regulatory strategies for targeted biologics to treat cancer. Furthermore, the RA Director will represent the Jounce R&D team before health authorities. Essential functions and professional experience include the following:

     

    Essential Functions

    • Responsible for developing innovative global regulatory strategies for assigned programs and working with the regulatory team on execution.
    • Represents regulatory affairs on cross-functional project teams to provide regulatory guidance and education through the interpretation of regulations, policies, procedures, guidelines, and compliance requirements.
    • Develops and manages regulatory submissions and related supplements and amendments
    • Responsible for maintaining and updating the regulatory strategy document and target product profile for assigned programs.
    • Interacts directly with health authorities and maintains excellent relationship with regulatory personnel.
    • Adept at integrating biomarker/companion diagnostic strategies into the development of assigned programs.
    • Educates company on regulatory requirements and evolving trends and disseminates regulatory intelligence relevant to the business.
    • Provides regulatory due diligence assessments of new business opportunities.
    • Contributes to the hiring and development of team members to become leaders.

    Qualifications

    • Advanced degree in a scientific or health-related field
    • 10+ years of regulatory affairs experience in the biopharmaceutical industry
    • Experience in providing strategic advice on integrated regulatory development plans and executing the regulatory strategy for assigned programs
    • In-depth working knowledge of regulations, guidance, policies, and procedures pertinent to drug and biologics development and operational knowledge of IND/CTA and NDA/BLA/MAA submissions
    • Experience with development of biomarkers and IVD companion diagnostics devices preferred
    • Strategic thinker with excellent problem solving and influencing skills
    • Exceptional communication and presentation skills to ensure the regulatory strategy is clearly articulated in cross-functional teams
    • Exceptional writing skills with experience in drafting and submitting timely drug and biologic applications to health authorities
    • Track record of building an excellent relationship with the FDA and other regulatory agencies
    • Quality mindset

     

    To apply, please submit you resume here:

    https://careers-jouncetx.icims.com/

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