Regulatory Affairs Submission Associate

Job Title: Regulatory Affairs Submission Associate

Location: Maidenhead

Contract: 12 months

Hours: 37.5 hours

Rates: £20-22p/h

• 
  
• Establish and maintain submission content planners and associated timelines; facilitate tactical submission team meetings; prepare content planners for publishing; interface with publishing vendor; and fulfil Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
  
• Manage low to medium impact submission projects to ensure timely delivery of high quality dossiers that meet regulatory specifications and are easily navigable and reviewable by regulatory agencies.
  
• Act as Submission Management support to project teams, providing guidance and communication of established submission processes and standards; contribute to project publishing timelines and deliverables.
  
• Participate in submission team meetings; expedite, manage, and coordinate multiple concurrent interrelated activities for submission projects to deliver low to moderately complex published submissions within required timelines; anticipate obstacles and propose solutions.
  
• Coordinate submission publishing with offsite publishers and notify stakeholders to ensure resources meet submission timelines; prepare content planner for publishing and work with vendors to resolve publishing issues.
  
• Facilitate the creation or procurement of submission content deliverables such as cover letters and forms.
  
• Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance, including verification of content, bookmarks, hypertext links, and table of contents in low to moderately complex submissions; facilitate team reviews.
  
• Contribute to the development of optimal business processes and standards within the department to ensure high levels of customer support and high quality submissions; contribute to internal process and standards documents relating to publishing and publishing deliverables.
  
• Suggest and contribute to process improvements, including changes to software and business processes; may participate on internal project teams to update business software.
  
• Demonstrate ability to influence without direct authority; build and maintain positive relationships internally and externally.
  
• Position accountability/scope:
  
  • 
    
  • Supervision required
    
  • Receives project assignments from manager but has responsibility for managing own projects with oversight
    
  • Reviews project progress with manager on a regular basis with direction provided by manager
    
  • May assist with onboarding staff
    
  
  
  

• 
  
• Bachelor's degree
  
• Note: Years of experience may also compensate for lower education.
  
• PMP and RAC certificates are desirable.
  

• 
  
• Pharmaceutical or industry related experience
  
• Experience working in a complex and matrix environment
  
• Strong communication skills both oral and written
  
• Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
  
• Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred
  
• Proven leadership skills and presence
  

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy