Jobs
>
Norwood

    Senior Director/Director, Global Regulatory Affairs - Norwood, United States - Corbus Pharmaceuticals

    Corbus Pharmaceuticals
    Corbus Pharmaceuticals Norwood, United States

    3 weeks ago

    Default job background
    Description

    Job Description

    Job DescriptionCompany Description

    Corbus Culture:

    Our passion. Our purpose. At Corbus, it starts at our core.

    We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and grow. At Corbus, transformative ideas can come from anyone, anywhere and anytime. We offer our team flexibility and the opportunity to excel in their professional journey. We provide a welcoming space where collaboration, mentorship and diversity are encouraged. We come together, like no other, to elevate each other and focus on what's best for patients.

    About Corbus

    Corbus is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Our pipeline is comprised of two experimental drugs targeting solid tumors: CRB-701, a next-generation antibody drug conjugate ("ADC") that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload and CRB-601, an anti-integrin monoclonal antibody that blocks the activation of TGFβ expressed on cancer cells. The pipeline also includes CRB-913, a highly peripherally restricted cannabinoid type-1 ("CB1") receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit Connect with us on Twitter, LinkedIn and Facebook.

    Corbus Pharmaceuticals Holdings, Inc. is an equal opportunity employer

    Job Description

    General Description:

    As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus' drug development by developing and overseeing the execution of regulatory strategy in the US/EU and other territories deemed applicable.

    Responsibilities:

    • Collaborate with the leadership team to develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible.
    • Proactively identifying regulatory risks and working with the Corbus Product Development Team to mitigate those risks.
    • Leading working groups tasked with developing regulatory submissions e.g. IND working group.
    • Overseeing clinical trials submissions performed by Contract Research Organizations (CRO) ensure timely and good quality submissions supportive of the overall
    • Providing regulatory input on safety documentation e.g. Development Safety Update Report (DSUR), Investigator's Brochure (IBs)
    • Providing regulatory input on clinical documentation as required e.g. Protocols, Clinical Study Reports (CSR)
    • Reviewing external communications e.g. Publications, Press Releases, postings for regulatory compliance
    • Identifying and managing subject matter experts engaged to support regulatory activities
    • Ensuring that Corbus has a complete record of all regulatory submissions made by the company or on behalf of the company.
    Qualifications

    Qualifications and Experience:

    • Bachelor's Degree in life sciences
    • Higher degree preferred or equivalent experience
    • 15+ years' experience in biotech or pharma with 10+ years in Regulatory Affairs
    • Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA.
    • Experience with filing Orphan Drug Designations (ODD), FastTrack, Breakthrough Designations (BTD) and Priority Medicines Initiatives (PRIME) and other accelerated regulatory pathways ideal.
    • Ideally this role will be located in Norwood, Massachusetts as a hybrid role 3 days onsite weekly but flexible for remote candidates open to travel monthly to Norwood, Massachusetts.

    Qualities:

    • Demonstrate a collaborative leadership style within the Product Development Team when providing regulatory expertise.
    • Prepared to be hands-on as well thinking strategically.
    • Communicate well with internal and external stakeholders.
    • Be able to effectively articulate to Senior Management regulatory risk and the potential impact.
    Additional Information

  • SIEMENS AG

    Head of Regulatory Affairs

    2 weeks ago

    SIEMENS AG Walpole, United States

    Serving as a key and active member of the POC leadership team, interacting with the team and other business functions to ensure objectives are aligned and that the company is performing to operational objectives. Leading, coaching and mentoring the R Regulatory Affairs, Regulator ...

  • Siemens Corporation

    Head of Regulatory Affairs

    2 weeks ago

    Siemens Corporation Walpole, United States

    Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. · Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibi ...

  • Third Rock Ventures

    Regulatory Affairs

    1 day ago

    Third Rock Ventures Waltham, United States

    The position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...

  • Philips

    Regulatory Affairs Specialist

    1 week ago

    Philips Cambridge, United States Full time

    JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...

  • Philips

    Regulatory Affairs Specialist

    2 weeks ago

    Philips Cambridge, United States Full time

    JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...

  • Dyne Therapeutics

    Director of Regulatory Affairs

    4 weeks ago

    Dyne Therapeutics Waltham, United States

    Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide the ...

  • Dyne Therapeutics

    Director, Regulatory Affairs

    1 week ago

    Dyne Therapeutics Waltham, United States

    Company Overview: · Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide th ...

  • Corbus Pharmaceuticals

    Senior Director/Director, Global Regulatory Affairs

    3 weeks ago

    Corbus Pharmaceuticals Norwood, United States

    Company Description · Corbus Culture: · Our passion. Our purpose. At Corbus, it starts at our core. · We look for unique talent. Our people are brilliant, they break barriers and are not defined by a title. Eclectic experiences make Corbus a special place to share ideas and gro ...

  • Vigil Neuroscience

    VP, Regulatory Affairs

    4 weeks ago

    Vigil Neuroscience Watertown, United States

    Vigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of mo ...

  • Deciphera Pharmaceuticals

    Manager, Regulatory Affairs

    2 weeks ago

    Deciphera Pharmaceuticals Waltham, United States

    Company Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...

  • Apellis

    Director, Regulatory Affairs

    1 day ago

    Apellis Waltham, United States

    Job Description · Job DescriptionPosition Summary: · The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). · Key Responsibilities ...

  • Vigil Neuroscience, Inc.

    VP, Regulatory Affairs

    3 weeks ago

    Vigil Neuroscience, Inc. Watertown, United States

    Job Description · Job DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. ...

  • Deciphera Pharmaceuticals

    Manager, Regulatory Affairs

    3 weeks ago

    Deciphera Pharmaceuticals Waltham, United States

    Job Description · Job DescriptionCompany Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhib ...

  • Philips

    Regulatory Affairs Specialist

    1 week ago

    Philips Cambridge, United States Full time

    Job Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...

  • Relay Therapeutics

    Director, Regulatory Affairs

    4 hours ago

    Relay Therapeutics Cambridge, United States

    The Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Yo ...

  • Randstad

    Regulatory affairs specialist

    4 weeks ago

    Randstad Cambridge, United States

    job summary: · Your Responsibilities: · As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: · 1. Advise internal stakeholders (m ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Manager

    1 day ago

    Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: · However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requiremen ...

  • Korro Bio, Inc.

    VP Regulatory Affairs

    3 days ago

    Korro Bio, Inc. Cambridge, United States

    Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...

  • Discera Search

    Head of Regulatory Affairs

    4 weeks ago

    Discera Search Boston, United States

    Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. · Be the go for all things regulatory and actin ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Manager

    2 weeks ago

    Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements ...