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Associate Director Regulatory Program Manager.

Company: Johnson & Johnson
Location: Spring House
Posted on: January 16, 2022

Job Description:

Janssen Research & Development, L.L.C. is looking to hire an Associate Director, Regulatory Program Manager, to be located in Spring House, PA, Titusville, NJ, Raritan NJ, USA, Belgium or Netherlands

The Regulatory Program Manager (RPM) functions as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts. The RPM is accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. This individual provides operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed. RPMs are guided in all matters by our J&J Credo values and our Leadership Performance Standards.

Key Responsibilities

  • Empower teams to deliver the highest possible impact for our programs, business, and patients around the world.
  • Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings and additional major regulatory milestones.
  • Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration. Drive escalation and represent submission team at governance meetings.
  • Submission Leader tasked with driving project management of the submission team by setting direction, raising issues, establishing team R&Rs, developing detailed submission plans, and maintaining a close eye on critical path and associated analytics.
  • Support GRT in a manner that fosters and maintains a high-performance team culture, leading both submission kick off meetings and submission working group meetings and GRT-level meetings as required.
  • Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status. Liaise with CDT or SLT partners to prepare discussions and drive meeting outcomes. throughout the team and between co-development partners and/or other external partners, as required.
  • Provide global, cross-functional, operational leadership and management to drive risk management, prioritization, and decision-making, challenging the status quo and driving innovation. Drive global priority setting and gain buy in from commercial and SLT partners.
  • Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments.
  • Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy.
  • Drive process improvements and embed best practices from across programs, TA's and functions into supported teams.
  • Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery.
  • Drive RPM team forward by defining required areas of need, opportunity and continuous improvement and leading and sponsoring work streams to enable capabilities and enhance impacts.
  • Serve as a mentor and coach other RPMs
  • As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware.
  • Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required

    Qualifications

    A minimum of a Bachelor's degree is required.

    Post-graduate degree in life sciences, business management, regulatory affairs or related field is highly preferred.

    Regulatory certification (RAC) is preferred.

    Project management certification highly preferred.

    Required

    Experience and Skills:
    • A minimum of 7 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector.
    • Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents) in various phases of drug development cycle
    • Leadership and management of global submission teams in a matrixed setting (including work with external partners), with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan.
    • Demonstrated experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines
    • Demonstrated understanding and experience of Global Regulatory Affairs processes
    • Knowledge of global regulations, guidelines and regulatory requirements with in depth knowledge of FDA/EMA procedures
    • Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred).
    • Demonstrated ability to resolve controversy and influence teams without formal authority.

      Preferred
      • Experience with clinical trial teams and conduct, Phase I-Phase III.

        Other
        • Proficient in written and spoken English
        • Minimal local travel between sites
        • Ability to work virtually

          Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

          Primary Location

          Belgium-Antwerp-Beerse-

          Other Locations

          Europe/Middle East/Africa-Netherlands, North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House

          Organization

          Janssen Pharmaceutica N.V. (7555)

          Job Function

          R&D

          Requisition ID

          2105951824W

Keywords: Johnson & Johnson, Philadelphia , Associate Director Regulatory Program Manager., Executive , Spring House, Pennsylvania

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