job title: Regulatory submission specialist (gsk)

Roles and Responsibilities

• Awareness of the pharmaceutical industry, drug development environment, and R&D processes and objectives.

• Awareness of Regulatory Affairs responsibilities from pre-IND through Phases I-IV

• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.

• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

• Ability to interpret regulations

• Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices

• May be responsible for leadership of relevant submission team for product regulatory authority submission or maintenance activities associated with an approved product (including product renewals, site registrations/renewals/variations, label harmonisation, periodic benefit risk evaluation reports (PBRER) submissions etc)

• May be required to provide guidance to project teams and client groups on GSK submission related processes and content and format requirements for key markets.

Other Qualifications -

• Good written and verbal communication skills and ability to present information in a clear and concise manner

• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.

• Ability to work flexibility in large teams.

Education Qualifications -

• Minimum level: Degree in a biological, healthcare or scientific discipline or Extensive experience within the drug development environment

• Preferred level: Bachelor degree or higher in biological or healthcare science