Jobs
>
New York City

    Manager, Global Regulatory Affairs CMC - New York, United States - Takeda Pharmaceutical Company Ltd

    Show more Collapse job
    Default job background
    Description


    By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use.

    I further attest that all information I submit in my employment application is true to the best of my knowledge.

    Job Description


    Takeda Development Center Americas, Inc.

    is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:
    Masters degree in Regulatory Affairs or related field plus 2 years of related experience


    Prior experience must include:

    Develop the regulatory submission strategies for products in commercial and development phase by working in close coordination with the quality, manufacturing and global regulatory teams; Ensure the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions; Submit the compliance submissions such as annual reports (BLA), yearly biologic periodic reports and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements; Provide regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada as well as liase with in-country regulatory representative to provide the assessments.

    Up to 20% remote work allowed.

    Full time. $133,200.00 to $223,200.00 /year.

    Apply on-line at and search for Req #R

    Locations

    Boston, MA

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time

    We have other current jobs related to this field that you can find below


  • Varite Short Hills, United States

    Job Description: · PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. · Responsibilities will include, but a ...


  • Stellar Consulting Solutions, LLC Rahway, United States

    Job Description: · Job Title: Project Manager (CMC 2 Regulatory affairs) · Location: Rahway, NJ - Onsite · Pay rate: $50/hr on C2C OR $40 on W2 · Qualifications: · • Experience should be 4 to 7 years · • Bachelor's or master's degree required in science, engineering or related f ...


  • Varite Short Hills, United States

    Pay rate range: $40-43/hr. · Job Title: CMC 2 Regulatory affairs · Location: Rahway, NJ - Onsite · Responsibilities: · Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States · Manag ...


  • Varite Short Hills, United States

    Job Title: CMC 2 Regulatory affairs · Location: Rahway, NJ - Onsite · Responsibilities: · •Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States · •Manage execution / authoring and ...


  • Katalyst Healthcares and Life Sciences Rahway, United States

    Responsibilities:Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States. · Manage execution/authoring and review of CMC documentation (Module 1, 2 and 3/Part II) for life cycle managemen ...


  • Cynet Systems Rahway, United States

    Job Description: · Pay Range $38hr - $43hr · Responsibilities: Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference Member States. · Manage execution / authoring and review of CMC documentation (Modul ...


  • Katalyst Healthcares and Life Sciences Rahway, United States

    Responsibilities: We are inviting applications for the role of CMC 2 Regulatory affairs. Responsibilities: · Well versed in performing CMC compliance activities including Gap Analysis and assessment for Annex 3 comparative table with reference EU Member States · Manage executio ...


  • Varite Short Hills, United States

    Pay rate range:$35-40/hr. · Job Description: · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · " Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Mem ...


  • Bayer CropScience Limited Hanover Twp, United States

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspe ...


  • Takeda Pharmaceutical Company Ltd Flushing, United States

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment applica ...


  • X4 Life Sciences New Jersey, United States

    A long term consulting client of X4 Life Sciences is looking to add a Regulatory Affairs Subject Matter Expert to their division, · Our client are an expert in providing their clients with solutions to their most difficult drug development challenges as well as regulatory framewo ...


  • EPM Scientific New Jersey, United States

    Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join their growing team. This exciting opportunity offers the chance for a leader with clinical regulatory affairs experience to take on a hands-on leadership role. T ...


  • SciPro New Jersey, United States

    Our client, an exciting and growing Biotech Company, is seeking a Regulatory Affairs professional at the Senior Director level. This role will lead the North America regulatory strategy and work extremely closely with the C-Suite leaders of the business. They are focused on Autoi ...


  • Navitas Life Sciences New Jersey, United States

    Job Title: Lead Regulatory Affairs · Work Location: US – EST, CST time zone. · Reports To: Practice Head - Regulatory · Job Description: · Develop and manage day-to-day operations using project management and planning tools, create and maintain detailed project timelines · Est ...

  • AA2IT

    Regulatory Affairs

    4 days ago


    AA2IT New York, United States

    Job Title: Regulatory Affairs - Animal Health · Location: Rahway, NJ - Onsite from day 1 · Pay Rate: $42/hr · Duration: 11 Months · We are inviting applications for the role of CMC 2 Regulatory affairs. · Responsibilities: · Well versed in performing CMC compliance activiti ...


  • EPM Scientific New York, United States

    The Company is a Pharmaceutical company that has a great underdog story. They started as a generic company until they hired a new CEO who has turned the company around. They went from struggling to now 3x their stock. Their main focus is on women's health. · Join our team as a Di ...


  • Columbia University New York, United States

    * Job Type: Officer of Administration · * Regular/Temporary: Regular · * Hours Per Week: 35 · * Salary Range: $86,000 - $98,000 · The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualif ...


  • Axsome Therapeutics, Inc. New York, United States

    Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disor ...


  • Scismic Inc New York, United States

    Job Description · Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. · The ...


  • Credit Agricole New York, United States

    Summary: · Â · Under the supervision of the FCS New-York, the Compliance Coordinator will work closely with the New York Compliance/ CPL team to support the implementation and execution of compliance initiatives, processes, and controls that manage compliance risks as well as act ...