Senior Regulatory Project Manager
Johnson & Johnson
High Wycombe, United Kingdom
9d ago

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.

We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.

Janssen Research & Development, LLC discovers and develops creative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

Please visit http : / / www.JanssenRnD.com for more information.

ROLE PURPOSE

You will provide regulatory support for a portfolio of promoted and non-promoted products ensuring that Regulatory documents are prepared in line with MHRA and HPRA requirements and accepted timelines.

You will manage all regulatory queries to ensure they are addressed promptly and you will be responsible for the content of the local labelling documents released to prescribers.

Initially your role will be focusing on projects with deadlines linked to the UK’s exit of the European Union in March 2019, However this will adapt as we pass this period and continue with the new challenges ahead.

KEY ACTIVITIES

  • You will ensure product information for prescribers and patient line are released within strict timelines
  • Preparing and distributing labelling documents within stipulated timelines
  • Preparing for and running local procedures following the EMEA Regulatory Affairs
  • Partnering with allocated commercial teams to provide regulatory expertise and support
  • Collecting regulatory competitive intelligence as required
  • Qualifications

    At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.

    We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science.

    Janssen Research & Development, LLC discovers and develops creative medical solutions to address meaningful unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.

    Please visit http : / / www.JanssenRnD.com for more information.

    ROLE PURPOSE

    You will provide regulatory support for a portfolio of promoted and non-promoted products ensuring that Regulatory documents are prepared in line with MHRA and HPRA requirements and accepted timelines.

    You will manage all regulatory queries to ensure they are addressed promptly and you will be responsible for the content of the local labelling documents released to prescribers.

    Initially your role will be focusing on projects with deadlines linked to the UK’s exit of the European Union in March 2019, However this will adapt as we pass this period and continue with the new challenges ahead.

    KEY ACTIVITIES

  • You will ensure product information for prescribers and patient line are released within strict timelines
  • Preparing and distributing labelling documents within stipulated timelines
  • Preparing for and running local procedures following the EMEA Regulatory Affairs
  • Partnering with allocated commercial teams to provide regulatory expertise and support
  • Collecting regulatory competitive intelligence as required
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