Regulatory Affairs-Senior Manager- English-Remote UK

Genpact

5 - 10 years

nan

Posted: 05/03/2025

Job Description

Responsibilities

  • Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
  • Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
  • Lead configuration requirements workshops, design, prototype, configure and document content solutions
  • Program and project management including resource planning, leading, and motivating a cross-functional team
  • Primary customer liaison managing communication between the project team, customer, and internal stakeholders
  • Mentor project team and consultants, helping others improve their consulting skills
  • Good years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative
  • In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
  • Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Influential; experience leading teams through hard decisions and negotiating compromises
  • Technical abilities and willingness to roll up your sleeves to design and implement a RIM solution
  • Expert on life sciences compliance and computer systems validation requirements
  • Ability to work independently in a dynamic environment
  • Typical travel is 25% but may be up to 50% based on customer requirements

About Company

Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.

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