GlaxoSmithKline Recruitment for Regulatory Specialist – Submission Coordination

Job Purpose:

The Job holder works with the Submission Coordination Project Lead, Senior Submission Coordinator or GRL/ Regional Rep/EU Agent (TG) or Functional teams or C&EP equivalent to ensure that appropriate content for specific submissions supporting R&D projects and Commercial is developed and delivered to agreed timeframes and in compliance with GSK processes and policy as they apply to the role.

Key Responsibilities:

• With management oversight, accountable to deliver to Project Lead, Senior Submission Coordinator or GRL/ Regional Rep/ EU Agent/ C&EP TG/LOC (or equivalent) with input from Functional teams (e.g. CMC/Clinical/nonclinical etc.) for delivery of assigned submissions to agreed timeframes and appropriate content for Rest of the world (ROW) markets.
• Beginning to understand internal/external Regulatory environment
• Accountable to follow GSK ways of working/process Written Standards and develop understanding to achieve right first-time delivery.
• Begin to build organisational networks.
• Regular communication with line manager or technical lead/Functional teams/LOCs (or equivalent) to help identify and escalate any issues with business impact (e.g. submission package availability, change in local requirements).
• Manages routine project assignments with some level of support from manager (or delegate) or technical lead /Functional teams.
• With management oversight, ensures quality of both own and submission team’s work and compliance with regulatory guidelines and process as they apply to the role.
• Works with staff from other functions, and should be capable of working to senior levels in process development functions in provision of advice, interpretation of relevant guidances, researching topics and resolving issues.
• Responsible for coordinating the maintenance activities associated with an approved product, including product renewals, label harmonisation, PBRER submissions, Site Registrations/Site Renewals, Variations etc.
• With management oversight, participate in knowledge sharing in team meetings.
• May be required to liaise with Regulatory Agencies to resolve issues in relation to their accountabilities.

Basic Qualifications:

• Bachelor’s degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment

Preferred Qualifications:

• Master’s degree or higher in biological or healthcare science
• 1- 3 years of relevant experience (specific per region/location)
• General understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.
• Should be compliant of GSK values and expectations
• Service orientation, customer-focused
• Can identify areas for personal professional growth in Global Regulatory Affairs with appropriate support from line manager.