Job Description

Work Schedule Standard (Mon-Fri)Environmental Conditions OfficeThis a client dedicated role for a Regulatory Affairs Senior Specialist role.Job PurposeWorks 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 clients SOPs and working practicesMentors/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, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with clients 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, 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 clients submission related processes and content and format requirements for key markets
• May be required to lead or participate to process improvement initiatives
• May be required to take on additional Project Management responsibilities if identified as Single Point of Contact (SPOC) for the GRL.

• 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

• Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Broad knowledge of Regulatory Affairs responsibilities from MAA to 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.

• 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.
• Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
• Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management, etc.

Thermo Fisher Scientific