Regulatory Global Submission Manager
Siena, Italy
6 gg fa

342141 Regulatory Global Submission Manager / Project Manager

This is an excellent opportunity for either an established Project Manager in the Life Sciences industry or Regulatory Affairs professional looking to join a truly global team / role working across multiple therapy areas.

The job holder will work with global submission teams and third parties to project manage regulatory submissions (including global marketing applications, product line extensions and supplements) from submission through to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance and within GSK SOPs and working practices.

In this role you will

  • Be accountable to Global Regulatory Lead and Global Regulatory Affairs staff for the project management of major regulatory submissions
  • Perform scenario planning when multiple regulatory strategies are being considered
  • Maintain or provides inputs into plans which drive strategic resource planning
  • Through collaboration with contributing functional lines, create and maintain a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of that content, target governance board review timeframes, and credible dispatch and Health Authority approval dates for key markets
  • Lead submission planning discussions, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and / or timelines are assessed quickly throughout the submission process.
  • Provide various visuals, reports, scorecards, etc, to facilitate awareness of key milestones, closely monitors critical path activities, and ensures transparency of submission status to stakeholders.
  • Provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets
  • Utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure / format, associated GSK systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing rework to avoid costly time delays.
  • Be responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities.
  • Participate in discussions / meetings with Regulatory Authorities, as required, to develop and communicate submission strategies for applications.
  • Closing Date for Applications : October 16th, 2022 (COB)

    Please take a copy of the Job Description, as this will not be available post closure of the advert.

    When applying for this role, please use the cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.

    The information that you have provided in your cover letter and CV will be used to assess your application.

    During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies.

    Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391.

    This will help us to understand any modifications we may need to make to support you throughout our selection process.

    Why you?

    Qualifications & Skills :

    We are looking for professionals with these required skills to achieve our goals :

  • Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment
  • Project management experience in the pharmaceutical industry or in a regulatory environment.
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • General knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV
  • Familiarity with Microsoft Project and / or other project management tools
  • Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
  • Proven ability to think flexibly in order to meet constantly shifting priorities and timelines.
  • Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
  • Effectively lead multidisciplinary team meetings and drive discussions regarding submission content, timelines, resource allocation, risk management, etc.
  • Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if / when to escalate issues, and effectively interact with stake holders to ensure transparency of submission progress / status.
  • Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
  • Preferred Qualifications :

    If you have the following characteristics, it would be a plus :

  • Global / RoW Regulatory experience
  • Demonstrated leadership and negotiation skills with ability to persuade and influence others (regardless of level) in achieving team objectives.
  • Excellent written and verbal communication skills and ability to present information in a clear and concise manner
  • Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
  • Sense of urgency and ability to work well in high pressure / high stress situations
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