• Regulatory Affairs Senior Project/Program Manager||Can be located in a

    From nomesh kumar@21:1/5 to All on Tue Jul 21 10:19:46 2020
    Hi ,,

    Greetings for the day!

    Hope you are doing Great!!

    We have immediate requirements for below positions. Please go through the descriptions and let me know if you are interested






    Can be located in a Plymouth Meeting, PA or Cranford, NJ offices. right now remote





    Regulatory Affairs Senior Project/Program Manager



    Position Description

    Our client has an immediate need for business support in their Regulatory function to support processing of Registration and Submission data from data creation through Submissions Publishing / eCTD submission and archiving. The client has recently
    implemented a new global RIM and Publishing Platform (AMPLEXOR) and has transitioned to a harmonized business process that represents a significant change to how several legacy business units operated. The candidate would be expected to collaborate with
    client and third party resources to provide program and project execution guidance, to track and drive progress of product submissions, and to assist in remediating any change management / process adoption challenges.





    Your future duties and responsibilities

    Project/Program Management background to help organize, rationalize, and align to an executable plan the set of disconnected activities currently being carried out inside the regulatory group.

    Key Areas of Responsibility would include:

    • Establishing (or reinforce) the clients RACI and Data Management Model with respect to Registration Data creation, ownership / stewardship, consolidation, and publishing • Creating and maintaining Product / Therapy Registration and Submission
    Project Plans to include all major steps in the cycle (registration and submission planning, document / artifact authoring/review/approval, submission (eCTD) assembly, submission publishing, submission archiving), as well as necessary support and
    compliance activities (change controls, training & change management,

    etc.)

    • Driving process visibility via existing Amplexor System Reporting and Trending Tools, as well as external Project Management Reporting and Tools • Enforcing data standards and surveilling projects to identify and break down any instances of siloed
    or offline work such that the client can take full advantage of their centralized RIM system





    Required qualifications to be successful in this role Candidates must have experience in regulatory affairs operations in a pharmaceutical environment, and should have background in the following:

    a. Submissions Planning and Registration Information Data Capture / Stewardship b. Regulatory Document authoring, review, and approval c. Submission Assembly (i.e. collecting Regulatory Documents and related data sets and creating a Submissions Package
    output, including experience with Electronic Common Technical Documents [eCTD]) d. Submission Publishing e. Submission Archiving Must also have strong organizational, communications and project mgmt. skills

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