Senior Regulatory Submissions Publisher - Contract

    Toronto, ON, Canada
    • Degree in Sciences with 3+ years regulatory publishing experin
    • Experience supporting eCTD in Canada
    • Experience in supporting CTA and their requirements

    Kelly Scientific Resources believes in relationships, not transactions. That’s why we’re committed to successfully matching job seekers with the best employers across Canada and around the world.  We fill positions from entry level to senior management, on a temporary or permanent basis. Whether your specialty is Science, Engineering, IT, Finance, Marketing, Manufacturing, Contact Centre or Business Administration, we’ll work with you to understand your likes, dislikes, goals and ambitions, and present you with opportunities that meet your needs. See what we have to offer.

    Looking for more?  Sign up for our Career Tips Newsletter to receive helpful tips and tricks monthly, connect with us on Facebook, LinkedIn & Twitter, or visit kellyservices.ca.

    Kelly Services (Canada) Ltd., is committed to providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

     

    SENIOR REGULATORY SUBMISSIONS PUBLISHER - Contract

    • Provide regional or global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.
    • Manage regional submissions as a lead publisher and support global submissions
    • Proactively communicate requirements and issues to be considered to the Submission Team, and contribute to achieving timelines.
    • Proactively collect necessary information from the Submission Team, and plan all submission management related activities.
    • Proactively communicate with cross-functional colleagues on submission requirements including eCTD
    • Liaise with global regulatory affairs staff regarding technical/format requirements on submission deliverables.
    • Perform quality checking of documents and regulatory submissions to ensure compliance with style and submission-ready standards.
    • Compile and publish regulatory submissions in accordance with current standards and processes using agreed upon tools.
    • Ensure printing and distribution of regulatory submissions, paper and electronic, as required.

    Qualifications: 

    • Bachelor’s degree or relevant equivalent experience
    • Three years pharmaceutical experience in a regulatory environment.
    • Two to four years experience with information management, document management technology, and electronic publishing software (Insight Publisher is an asset).    
    • Expertise in drug development, including knowledge of the contents/ formatting of regulatory submissions and product life-cycle and how other functions contribute to regulatory submissions
    • Knowledge of regulatory authorities requirements on electronic submissions in Canada.  Knowledge in also other regions an asset (e.g., US, EU, MEA, etc.)

    Experience: 

    • Specialist knowledge of pharmaceutical/biotech industry gained in operationally focused role 
    • Working in partnership with publishing vendors
    • Dossier and Submission related Regulatory Guidance for CANADA
    • Successful submission and maintenance of marketing applications

    Category: Biotechnology & Pharmaceutical

    Reference ID: CA7677BM001462

    Date Posted: 23/11/2019

    Shortcut: http://jobs.en.kellyservices.ca/BTcXS2

    Connect with Us
    Powered by SnapHop