Jobs
>
Redwood City

    Regulatory Director - Redwood City, United States - Longevitylist

    Longevitylist
    Longevitylist Redwood City, United States

    3 weeks ago

    Default job background
    Description
    At cellvie

    , we are leveraging the therapeutic potential of mitochondria, which will likely be regulated as a biologic. Based on augmentation and replacement, an approach developed at Harvard, we are building a medicinal platform, with first applications in heart attack patients and organ transplant recipients.

    cellvie

    is a venture-backed start-up with primary activities in Zurich.
    We are looking for a highly motivated, diligent and pragmatic regulatory expert.

    You should have at least 8 years of experience in bringing biological medicinal products to market – ideally having worked with or in an early stage company.

    Tolerance for ambiguity and the capacity to self-sufficiently acquire new knowledge in your as well as in adjacent fields are indispensable.


    What we are offering:
    The role of Regulatory Director, working directly with the company's founders and leadership team
    The chance to work on the development of a novel treatment modality - mitochondria
    Great responsibilities and degrees of freedom to develop and execute cellvie's regulatory strategy
    A varied task environment extending beyond regulatory submissions – e.g. to supporting the development of a quality management system and a GMP manufacturing process
    A highly dynamic and entrepreneurial environment
    Competitive pay and equity package

    Who we are seeking:


    You are expected to be self-motivated and resourceful, and as apt at efficiently applying your knowledge as you are in extending it.

    You should have ample experience in bringing biological products towards approval and ideally, you have already worked in an early-stage company.

    Experience in QMS and GMP and GLP would be valued.
    In-depth knowledge in pursuing regulatory approval for biological medicinal products
    Ability to work independently and truly drive the approval-relevant activities
    Being well-organized and diligent, with a healthy pragmatism to make decisions under ambiguity
    The openness and ability to acquire new knowledge
    A talent for writing
    Other qualities
    Full proficiency in English
    Experience in QM

    Who we are:
    cellvie

    is a venture-backed biotechnology start-up, bringing about mitochondria-based therapies
    We are a team of like-minded individuals, passionate about our technology and the problems we seek to solve
    We are eager to go the extra mile and take pride in and joy from our work
    We have shown the safety and efficacy of our therapy in pre-clinical studies and in a first clinical pilot and are now focusing on the commercial translation of the technology in a variety of fields
    Investing in the Longevity Biotechnology Revolution. By Nathan Cheng + Longevity List.

    Company SummaryJuvena Therapeutics is on a mission to discover and develop biologics for rare and chronic degenerative diseases by mi...

    Position DescriptionWe are seeking a talented Senior Research Associate / Scientist to be an integral part of our drug discovery plat...

    Company SummaryJuvena Therapeutics is on a mission to discover and develop biologics for rare and chronic degenerative diseases by mi...

    #J-18808-Ljbffr
  • Metropolitan Transportation Commission

    Assistant Director, Regulatory

    5 days ago

    Metropolitan Transportation Commission San Francisco, United States

    **DESCRIPTION**: · **THIS JOB POSTING WILL REMAIN OPEN UNTIL A QUALIFIED POOL OF APPLICANTS IS ESTABLISHED** · **FIRST REVIEW OF APPLICATIONS WILL BE ON WEDNESDAY, MAY 1, 2024** · **IF YOU ARE INTERESTED, PLEASE APPLY IMMEDIATELY** · **First round interviews **tentatively **sched ...

  • Coherus BioSciences

    Regulatory Affairs Director

    2 weeks ago

    Coherus BioSciences Redwood City, CA, United States

    Title: Director, Compliance · Reports To: Head of Quality · Location: Redwood City, California · Classification: Exempt · Overview: · Principle Responsibilities and Duties: This position is responsible for establishing and implementing global compliance systems for operation ...

  • Meet

    Senior Director Regulatory Affairs

    1 week ago

    Meet Redwood City, United States

    Exciting Opportunity in Regulatory Affairs - Sr. Director · Location: Redwood City, CA (Onsite 3 days per week) · Company Overview: · A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. ...

  • Meet

    Senior Director Regulatory Affairs

    6 days ago

    Meet Redwood City, United States

    Exciting Opportunity in Regulatory Affairs - Sr. Director · Location: Redwood City, CA (Onsite 3 days per week) · Company Overview: · A pioneering biotechnology company, at the forefront of cortisol modulation research and development, is seeking a dynamic Regulatory Affairs Sr. ...

  • Arcellx, Inc.

    Director, Clinical Regulatory Affairs

    5 days ago

    Arcellx, Inc. Redwood City, United States

    Senior Director, Clinical Regulatory Affairs · Redwood City, CA · Size · Size · Width: · Height: · Position · Position · X: · Y: · No Videos Found · Would you like to import a video? · OR - Select the videos you would like to feature · Import video from YouTube or Vimeo · ...

  • Biomea Fusion, Inc.

    Director-Sr. Director, Global Regulatory Affairs

    3 weeks ago

    Biomea Fusion, Inc. Redwood City, United States

    At Biomea Fusion, Inc., we aim to cure in oncology and diabetes. We are seeking an experienced and highly motivated regulatory professional to support our clinical development programs and future marketing applications. Reporting to the Executive Director, Regulatory Affairs, the ...

  • FusionHealth

    Director-Sr. Director, Global Regulatory Affairs

    2 weeks ago

    FusionHealth Redwood City, United States

    At Biomea Fusion, Inc., we aim to cure in oncology and diabetes. We are seeking an experienced and highly motivated regulatory professional to support our clinical development programs and future marketing applications. · Reporting to the Executive · Director, Regulatory Affair ...

  • Cargo Therapeutics

    Associate Director, CMC Regulatory

    2 weeks ago

    Cargo Therapeutics San Carlos, United States

    Job Description · Job DescriptionReporting to the Vice President, CMC Regulatory, CARGO is seeking an Associate Director, CMC Regulatory to help progress development of our cell-based gene therapy portfolio. The successful candidate will have a strong background in regulatory CMC ...

  • Allakos Inc

    Executive Director, Regulatory Affairs CMC

    3 weeks ago

    Allakos Inc Redwood City, United States

    Exec Director Regulatory Affairs/CMC · Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases. · The Executive Director, CMC Regulatory Affairs is responsible for devel ...

  • Arcellx, Inc.

    Senior Director, Clinical Regulatory Affairs

    2 weeks ago

    Arcellx, Inc. Redwood City, United States

    Who We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...

  • Corcept Therapeutics

    Sr. Director, Regulatory Affairs

    3 weeks ago

    Corcept Therapeutics Menlo Park, United States

    Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. · In 2012, we received FDA app ...

  • Arcellx, Inc.

    Senior Director, Clinical Regulatory Affairs

    3 weeks ago

    Arcellx, Inc. Redwood City, United States

    Who We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...

  • Arcellx

    Senior Director, Clinical Regulatory Affairs

    3 weeks ago

    Arcellx Redwood City, CA, United States

    Who We Are · Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our missi ...

  • Andromeda Surgical

    Director of Regulatory

    1 day ago

    Andromeda Surgical South San Francisco, United States

    Company Description · At Andromeda Surgical, we are developing autonomous robots with the goal of making surgical procedures safer, easier, and more efficient. We are starting with a urologic procedure that has superior outcomes but a steep learning curve that has limited its ado ...

  • Ascendis Pharma

    Associate Director, Regulatory Affairs

    2 weeks ago

    Ascendis Pharma Palo Alto, CA, United States

    The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, ...

  • Ascendis Pharma A/S

    Associate Director, Regulatory Affairs

    2 weeks ago

    Ascendis Pharma A/S Palo Alto, United States

    The Regulatory Affairs (RA) Associate Director, Labelling will be responsible for labelling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. · The RA Associate Direct ...

  • Ascendis Pharma

    Director, Regulatory Affairs, Oncology

    2 weeks ago

    Ascendis Pharma Palo Alto, CA, United States

    The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans for project teams wi ...

  • Meet Recruitment

    Senior Director, Regulatory Affairs, Ad/Promo

    1 week ago

    Meet Recruitment Menlo Park, United States

    Senior Director, Regulatory Affairs - Advertising and Promotion · *Hybrid Role - Menlo Park, CA* · Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders. Our client has an approved product and a dynamic la ...

  • Gilead Sciences

    Sr Director, CMC Regulatory Affairs

    6 days ago

    Gilead Sciences Foster City, United States

    Sr Director, CMC Regulatory Affairs –Small Molecules · Job Description · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that ...

  • Mirum Pharmaceuticals

    Director, Global Regulatory Affairs Labeling

    2 days ago

    Mirum Pharmaceuticals Foster City, United States

    POSTION SUMMARY · The Director, Regulatory Affairs Global Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed pro ...