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Associate Director / Director Global Regulatory Affairs

GSK
Job LocationBrentford
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: Switzerland - Zug, UK - London - BrentfordPosted Date: Jun 18 2020GSK Global Regulatory Affairs is seeking an Associate Director/Director that can provide critical strategic and operational regulatory leadership across the Oncology portfolio of products that require the co-development and registration of a diagnostic. The successful applicant will also provide medical device regulatory strategic support in the area of use of real world data as applicable to regulatory strategy and serve as a resource for the evaluation of stand-alone medical devices and in vitro diagnostic tests of interest to GSK. Prior experience in laboratory testing or diagnostics is highly preferredEnsure the development of appropriate global and/or regional regulatory strategy(s) including EU and their execution for assigned asset(s) consistent with Medicines Development Strategy to ensure the development program meets the needs of the key markets identified and the Medicine Profile. This goal has to be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements to deliver the best possible labeling to meet the Medicine Profile, commensurate with the available data.Responsibilities and Accountabilities:Accountable to GRL or Senior Director/Head of CDx Regulatory, for development of appropriate global regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK, reviewing, contributing and editing submission dossiers, and representing GSK with the regulatory agency. Work with the MDT to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified and the Medicine Profile. Lead interactions with local / regional /global regulatory authorities. In performing the role, the job holder will be responsible for:

  • Work within Oncology Global Regulatory Affairs, be capable of developing regulatory/validation strategies for the development and registration of companion diagnostics through laboratory based tests or a commercial in vitro diagnostic test kit.
  • Work directly with the Medicines Development Team (MDT), the Global Regulatory Lead and the Biomarker/Diagnostics Development Leader within Experimental Medicines Unit to assess the diagnostic test needs for the companion medication and determine the strategy for the development and delivery of the diagnostic test for use in the clinical development program and for the product post-approval.
  • Experienced in EU/EMA regulations as it applies to precision medicines and IVDs, including CE mark, and evolving IVDR and MDR regulations. Additionally, awareness of global regulatory landscape for companion diagnostics, medical devices and combination products will be advantageous.
  • Experienced in determination of the regulatory options and the relative risk and benefits of various diagnostic test options and in thinking of innovative regulatory strategies for study risk determination, IDEs, PMA submissions
  • Work with cross-disciplinary team to determine a transition “bridging” strategy for laboratory based tests used during the clinical development program to an in vitro diagnostic or a laboratory-developed FDA approved test at the time of drug product approval.
  • Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective and the impact this will have on the regulatory strategy for an asset.
  • Work alongside other core members of the MDT and/or EDT providing broad development input/expertise to their programs (over and above regulatory input).
    • Basic Qualifications
  • Master’s or PhD in biological or healthcare science preferred
  • Extensive experience and demonstrated success in companion diagnostic or medical device regulatory affairs with focus on EU and global regulations
  • Prior Oncology Therapy Area experience preferred
  • Proven experience of submission and approval activities in global/local region(s) including track record of organising and executing successful milestone meetings and proven track record of successful relationship with one or more Health Authority
  • Extensive knowledge of clinical trial and licensing requirements in all key markets in the region and sound knowledge globally. Ideally, proven experience of leading regulatory activities outside local region.
    • Preferred Qualifications Competencies and Capabilities
  • Outstanding communication skills, both in writing and verbally. Delivers all communication with clarity, impact and passion, tailored to the audience. Commands attention and interest through the use of a range of communication techniques and styles. Makes complex ideas simple.
  • Consistent ability to foster strong matrix working. Proven track record of facilitating groups of individuals to work together on creating solutions. Supports team members to see how their ideas can be combined in order to create value for the whole group. Ability to lead change and communicate difficult messages. Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more. Ensures implementation of longer term plans or delivery of large scale projects
  • Proven ability to build strong personal networks, both within and outside GSK and use them to secure appropriate support and outcome for a project.
  • Proven ability to recognize and resolve conflict and arbitrate as necessary, using sound judgment in reaching win-win solutions
  • Proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions. Capable of synthesizing complex information globally to ensure appropriate assessment of the “big picture” for a project
  • Proven ability to take sound decisions, often without complete information, or in situations where consultation with others is not possible due to situation or time constraints. In doing so, the job holder will proactively seek information and insight from a broad range of sources and weight benefits and risks before making important decisions.
  • Shows a constant focus on improving performance and excellence in all tasks. Challenges and questions ways of working to seek improved process. Adds value through quantitative goal setting and provision of feedback to raise collective performanceStrong overall business acumen. Understands the needs of other functions. Understands the competive landscape in the commercial

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