Sr Reg Affairs Spec

Work Schedule

Environmental Conditions

Job Description

Job Purpose

Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams and Local Operating Company regulatory contacts to deliver submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with client's SOPs and working practices.

Mentors/coaches/trains other team members and reviews work to ensure right first-time submissions.

Key responsibilities

• Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with client's 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 perform scenario planning when multiple regulatory strategies are being considered and propose as necessary delivery strategies to achieve accelerated timelines.
• May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities
• May be the primary contact for the GRL, maintaining the overall RMT workplan (including relevant regulatory milestones according to the phase of development)
• May be required to provide guidance to project teams and client groups on client's submission related processes and content and format requirements for key markets
• May be required to lead or participate to process improvement initiatives

Education Requirements

• 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 

Job Related Experience (minimum requirements)

• General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• General knowledge of Regulatory Affairs responsibilities for Lifecycle management
• 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.
• 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.

Other Job-Related Skills

• Excellent 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 in a matrix environment, ensure delivery of objectives across cross-functional teams