Jobs
>
Mississauga

    Compliance Project Manager H/F - Mississauga, ON, Canada - Juno Pharmaceuticals

    Juno Pharmaceuticals
    Juno Pharmaceuticals Mississauga, ON, Canada

    1 week ago

    Default job background
    Description
    Regulatory Affairs Project Manager Regulatory Affairs Project Manager

    A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding environment.

    Effectively manage assigned Regulatory Affairs projects independently and when needed incorporate the assistance of other staff or consultants to ensure a successful conclusion.



    • Review technical dossiers/packages for accuracy, completeness and compliance with Regulatory requirements and prepare gap reports.
    • Ensure that submissions meet format and content requirement as well as ensure the accuracy and completeness of statement, data and conclusion in reports and summaries for inclusion in Regulatory submissions.
    • Build and maintain a healthy working relationship with Regulatory Agencies. Use the relationship to understand expectations beyond that which is presented in guidelines and policy statements.
    • Organize and facilitate meetings and teleconferences to maintain progress of projects. Track critical attributes of projects to ensure accountability and efficiency.
    • Resolve any technical queries or deficiency letters relating to any submission in a timely manner within deadlines.
    • Collaborate with senior decision-makers to provide technical direction and prepare Regulatory strategies for new products under assessment.
    • Provide regulatory counsel to ensure that all activities comply with regulations. Provide cross-functional input from an operational, scientific and technical viewpoint.
    • Monitor regulatory maintenance of approved drug products. Maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.) Review Change Controls and determine filing requirements.
    • Review and approve product labelling to meet regulatory requirements. Review promotional material to ensure compliance to Health Canada regulations, PAAB guidelines and/or ASC guidelines (as applicable).
    • Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritizes other responsibilities to meet additional work requirements
    • Build and maintain a healthy working relationship with business partners.
    • Contribute to an efficient and effective regulatory affairs team.
    Regulatory Affairs Certification and/or a minimum of 5 years relevant experience in pharmaceutical Regulatory Affairs with Health Canada


    • Regulatory Affairs experience with FDA an asset
    • Detail oriented, superior problem-solving ability to identify solutions, planning, analytical and organizational skills to manage multiple concurrent projects within established timelines.
    • Strong computer skills including Microsoft Office Suite and Adobe Acrobat.

    Reports to:
    Regulatory Affairs Manager
  • Raise

    Project Manager Junior It9financial Pm)

    3 days ago

    Raise Mississauga, Canada

    **RESPONSIBILITIES** · - Usually inputs to one or several projects of a smaller nature with no direct reports. · - Plans and coordinates all aspects of internal information system-specific projects from initiation to delivery. · - Projects may involve network, server, or software ...

  • BGIS

    Project Manager

    1 week ago

    BGIS Toronto, Canada

    Who We Are · BGIS is a leading provider of customized facility management and real estate services. With our global team of over 6,500 individuals, we are dedicated to fostering innovation through the services we offer while actively seeking new opportunities that will drive inno ...

  • CIBC

    Senior Project Manager

    5 days ago

    CIBC Toronto, Canada Temps plein

    Nous bâtissons une banque axée sur les relations pour un monde moderne. Nous recrutons des professionnels talentueux et passionnés qui ont à cœur de faire ce qu'il faut pour nos clients. · À la Banque CIBC, nous misons sur vos forces et vos ambitions pour vous donner le pouvoir ...

  • Tree of Life Canada

    Project Manager

    1 week ago

    Tree of Life Canada Mississauga, Canada

    Overview: · **_ Our core purpose:_**: · - _ · **_"We are curators of unique brands, bringing elevated food and beverage experiences to Canadians."_** · - For more information please visit our website at: _ · - ._ · **_ · Tree of Life Canada ULC_**: · - is an Employer who strives ...

  • PSI Engineering

    Project Manager

    1 day ago

    PSI Engineering Mississauga, Canada

    The Company · PSI Engineering manufactures and integrates automated pack and sortation systems for high volume warehouse and distribution centers who serve the business to consumer (B2C) market, drastically improving throughput and accuracy while reducing labor costs. · The Proje ...

  • Consor

    Project Manager

    1 week ago

    Consor Mississauga, Canada

    The Opportunity: · What gets you out of bed each morning? Is it knowing you're pursuing your passion for designing and building roads and bridges? Is it that you're helping better the communities in which you live and work? Or is it that you get the opportunity to work on and lea ...

  • Peel District School Board

    Project Manager

    1 day ago

    Peel District School Board Mississauga, Canada

    **Job Summary** · Reporting to the Manager, SIS Modernization, the successful applicant will provide leadership by directing and managing project development from beginning to end while adhering to strict deadlines, schedules, quality controls and within budget. In addition, you ...

  • Maple Reinders

    Project Manager

    2 days ago

    Maple Reinders Mississauga, Canada

    **Job Description**: · **Electrical Project Manager** · As an Electrical Project Manager you will have the opportunity to manage exciting Civil and ICI projects working alongside other construction professionals who are passionate about the work they do. Leadership and accountabi ...

  • Acara Solutions

    Project Manager

    1 week ago

    Acara Solutions Mississauga, Canada

    **Project Manager** · Our client is a respected supplier of custom-designed equipment to steel manufacturers throughout North America. Due to its continued penetration of the market and sales growth, our client is seeking a Project Manager to join their team. This position would ...

  • EnVision Consultants Ltd.

    Project Manager

    1 week ago

    EnVision Consultants Ltd. Mississauga, Canada

    **This position is a hybrid (in-office/remote work) position, based out of our Mississauga or Pickering location.** · Our team of professional engineers, scientists, technologists, project managers and support staff bring decades of experience and knowledge for a wide range of en ...

  • Pet Valu

    Project Manager

    2 days ago

    Pet Valu Mississauga, Canada

    Location: Mississauga, Ontario · **Job Description**: · At Pet Valu we understand that your pet is part of the family, because we're devoted pet lovers too. We have been providing pets with everything they need to live healthy, happy, and active lives for more that 40 years. · Ou ...

  • AtkinsRéalis

    Project Manager

    1 week ago

    AtkinsRéalis Mississauga, Canada

    **Project Manager** · **Come join us in reshaping the future with AtkinsRéalis. AtkinsRéalis is dedicated in engineering a better future for our planet and its people.** · AtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a ...

  • SGK

    Project Manager

    1 week ago

    SGK Mississauga, Canada

    **SGK is a global packaging and brand experience company. From idea to implementation, we deliver packaging solutions and brand experiences that give brands the freedom to speak louder, scale faster and grow stronger. We simplify marketing and amplify brands to deliver value. SGK ...

  • Acara Solutions

    Project Manager

    4 days ago

    Acara Solutions Mississauga, Canada

    **Project Manager** · Our client is a respected supplier of custom-designed equipment to steel manufacturers throughout North America. Due to its continued penetration of the market and sales growth, our client is seeking a Project Manager to join their team. This position would ...

  • AtkinsRéalis

    Project Manager

    4 days ago

    AtkinsRéalis Mississauga, Canada

    **Project Manager - Standard Plant Candu Monark** · **Come join us in reshaping the future with AtkinsRéalis. AtkinsRéalis is dedicated in engineering a better future for our planet and its people.** · The Project Manager will report to the Project Director, Standard Plant - Cand ...

  • De Havilland

    Project Manager

    1 week ago

    De Havilland Mississauga, Canada

    De Havilland Aircraft of Canada Ltd. ('DHC') is a proudly Canadian aerospace company currently transitioning its corporate headquarters to Calgary, AB. DHC is undertaking a consolidation of its underlying subsidiary companies under a single brand currently offering engineering, a ...

  • Polar Racking

    Project Manager

    1 week ago

    Polar Racking Mississauga, Canada

    Polar Racking Inc. is a North American leader in the design, engineering and manufacturing of PV mounting systems. We are at the forefront of PV innovation, leading the industry in cutting-edge design with a focus on continuous innovation, with a vision to deliver the highest val ...

  • Obsidian Group Inc.

    Project Manager

    3 days ago

    Obsidian Group Inc. Mississauga, Canada

    Coordinate internal resources and third parties/vendors for the flawless execution of projects. · Ensure that all projects are delivered on-time, within scope and within budget. · Assist in the definition of project scope and objectives. · Ensure resource availability and allocat ...

  • Canam

    Project Manager

    6 days ago

    Canam Mississauga, Canada

    **Job Description**: · We are seeking a Project Manager - Industrial Automation to join our growing team. The Project Manager acts as the primary point of contact for all project-related inquiries and is responsible for overseeing the planning, execution, and delivery of special ...

  • Trapeze Group Limited

    Project Manager

    12 hours ago

    Trapeze Group Limited Mississauga, Canada

    Job Summary: · Who We Are · Trapeze Software Inc is part of Modaxo's transit portfolio, and an operating group of Constellation Software Inc. We design and deploy best-in class technologies like enterprise asset management, workforce management, mobility solutions, and more for p ...