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    Regulatory Affairs Program Director M/F - Cambridge, United Kingdom - ProductLife Group

    ProductLife Group
    ProductLife Group Cambridge, United Kingdom

    1 week ago

    Default job background
    Permanent contract
    Description

    Regulatory Affairs Program Director M/F - 080

    Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place.

    About us Group 10 Missions

    You will act as a direct point of contact with those clients and coordinate several outsourcing projects for their Regulatory Affairs activities (pre-MAA and post-MAA) in Europe. You main tasks will be to:

  • Ensure the project management of the programs (workload management, resource management and allocation, performance and quality review, cost review)
  • Ensure the line management of the employees onboarded and dedicated to those programs (training, individual development plan, salary review, promotion, support)
  • Ensure that all the information circulates from our internal teams to the clients and vice-versa (communication with the clients and key internal stakeholders at PLG)
  • Guarantee the good and qualitative delivery of RA services to the clients in the respect of the agreed timelines
  • Group 13 Profile

    -Hard skills:

    · 8+ years experience in European Regulatory Affairs

    · Knowledge of EU RA regulations for pharmaceuticals (NCEs, Biologicals and Biotech), Medical Devices, Combination products

    · Knowledge of EDMS, Regulatory Databases (Register)

    · Experience in line management

    · Experience in resource management

    · Experience in invoice management

    -Soft skills

    · Fluent English mandatory

    · Excellent communication skills

    · Top-notch organizational skills

    · Proven leadership skills

    · Business/Commercial acumen

    · Willingness to travel occasionally

    · Good IT skills/knowledge

    · Pro-active attitude and ability to work on own initiative as well as part of a team

    · Personal responsibility to ensure a high standard of work



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