Jobs
>
Cambridge

    Regulatory Affairs Manager - Cambridge, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Cambridge, United States

    3 weeks ago

    Default job background
    Description
    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, and may support business development activities.
    • Recognize, exemplify, and adhere to ICON's values which center around our commitment to People, Clients and Performance
    • Work closely with Supply Chain, Project Management, QA teams to identify process and procedure improvements and assist in implementation of continuous improvement measures to ensure dept expertise and to meet department goals.
    • Identify issues and address them in a timely manner, including preventive actions.
    • Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements.
    • Initiate regulatory submission when required and support ICON team with Regulatory Inspections
    • Effectively contribute to all the aspects of allocated projects in timely manner including, proactive identification of risks, scope change, regulatory implications for approval by VP/Directors.
    • Communicate/liaise with clients, regulatory agencies/competent authorities and/or other regulatory or Functional Experts on designated regulatory activities as required.
    • Apply scientific principles and maximize compliance to all aspects of regulatory activities undertaken.
    • To be familiar with and to work in accordance with relevant ICON SOP's and internal systems, GXP and appropriate regulations and guidelines.
    • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

    Requirements:

    • FDA 510K, FDA QSR (3+ years experience).
    • Excellent written and oral communication skills
    • Good written and spoken English.
    • Strong technical writing and editing skills.
    • Travel (approximately 10-20%) domestic and/or international.
  • Commonwealth of Massachusetts

    Manager, External Affairs

    1 week ago

    Commonwealth of Massachusetts Boston, United States Full time

    Description · The Executive Office of Labor and Workforce Development (EOLWD) is looking for a creative, organized, and collaborative individual to join the team as Manager of External Affairs. Reporting to the Director of Communications and working closely with the Chief of Sta ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Manager

    1 week 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 ...

  • Takeda Development Center Americas, Inc

    Manager, Regulatory Affairs CMC

    3 weeks ago

    Takeda Development Center Americas, Inc Cambridge, United States

    Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...

  • Editas Medicine

    Senior Manager, Regulatory Affairs

    2 weeks ago

    Editas Medicine Cambridge, United States Permanent

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...

  • Takeda Development Center Americas, Inc

    Manager, Regulatory Affairs CMC

    2 weeks ago

    Takeda Development Center Americas, Inc San Francisco, United States Permanent

    Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...

  • Editas Medicine

    Senior Manager, Regulatory Affairs

    2 days ago

    Editas Medicine Cambridge, United States

    Job Description · Job DescriptionAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harne ...

  • Global Partners

    Government Affairs Manager

    6 days ago

    Global Partners Watertown, United States

    We're hiring for a Government Affairs Manager who will be responsible for implementing strategies to advance the company's legislative and political agenda. Candidates should have a demonstrated ability to build trusted, direct relationships with key officials and policy staff. T ...

  • PSG Global Solutions

    Manager of Regulatory Affairs

    3 weeks ago

    PSG Global Solutions Cambridge, United States

    We're looking for a · Manager of Regulatory Affairs , working in · Biotechnology/Medical Devices · industry in · Cambridge, Massachusetts, United States . · Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, ...

  • PSG Global Solutions Careers

    Manager of Regulatory Affairs

    2 weeks ago

    PSG Global Solutions Careers Cambridge, United States

    Apply now and our proprietary system will quickly have you in front of a live recruiter. · The Opportunity · Description · We're looking for a Manager of Regulatory Affairs, working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. · Works ...

  • Sarepta Therapeutics

    Senior Manager, Regulatory Affairs CMC

    5 days ago

    Sarepta Therapeutics Cambridge, United States

    The Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA workin ...

  • Takeda Pharmaceutical Company Ltd

    Manager, Global Regulatory Affairs CMC

    1 week ago

    Takeda Pharmaceutical Company Ltd Boston, MA, 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 Privacy Notice and Terms of Use. I further attest that all information I subm ...

  • Takeda Development Center Americas, Inc

    Manager, Global Regulatory Affairs, Marketed Products

    1 week ago

    Takeda Development Center Americas, Inc San Francisco, United States Permanent

    Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory · Affairs, Marketed Products in Cambridge, MA to Assist the Global Regulatory Lead (GRL) and is accountable for working with regulatory regional leads, other functions and vendors to ensure global r ...

  • Deciphera Pharmaceuticals

    Manager, Regulatory Affairs

    3 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 ...

  • Mass General Brigham

    Sr. Regulatory Affairs Manager

    1 week ago

    Mass General Brigham Somerville, United States

    Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on implementation proje Regulatory Affairs, Manager, ...

  • Philips

    Sr. Manager Regulatory Affairs

    4 weeks ago

    Philips Cambridge, MA, United States

    Job TitleSr. Manager Regulatory Affairs Job Description · The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products, ensuring and maintaining ...

  • Global Partners

    Government Affairs Manager

    1 week ago

    Global Partners Waltham, United States

    We're hiring for a Government Affairs Manager who will be responsible for implementing strategies to advance the company's legislative and political agenda. Candidates should have a demonstrated ability to build trusted, direct relationships with key officials and policy staff. T ...

  • The Ladders

    Sr. Regulatory Affairs Manager

    1 week ago

    The Ladders Somerville, United States

    Mass General Brigham Health Plan is an exciting place to be within the healthcare industry. As a member of Mass General Brigham, we are on the forefront of transformation with one of the world's leading integrated healthcare systems. Together, we are providing our members with in ...

  • Global Partners

    Government Affairs Manager

    1 day ago

    Global Partners Waltham, United States

    We're hiring for a · Government Affairs Manager who will be responsible for implementing strategies to advance the company's legislative and political agenda. Candidates should have a demonstrated ability to build trusted, direct relationships with key officials and policy staff ...

  • Alkermes

    Manager/Senior Manager, CMC Regulatory Affairs

    6 days ago

    Alkermes Watertown, United States

    Job Description · Great Science. Deep Compassion. Real Impact. · Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction. · We are inspired by the courage and dete ...

  • The Fountain Group

    Regulatory Affairs Manager III

    3 weeks ago

    The Fountain Group Cambridge, United States

    The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows: · Job Description: · Pay: /hr on W2. · 6-month assignment t ...