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REGULATORY AFFAIRS OFFICER - Reading

Regulatory and Quality - Regulatory Affairs & Quality
Ref: 1029 Date Posted: Monday 14 May 2018
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Entrust People have a fantastic opportunity for a Regulatory Affairs Officer to join a global CRO.  The role will involve preparing and reviewing regulatory submissions to support clinical trial authorisation activities for both internal and external clients.  

RESPONSIBILITIES
• Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
• Competently reviews/writes regulatory and/or technical documents (including ICF) with minimal review by senior staff.
• Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues.
• Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate.
• May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
• May present to clients at bid defence meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
• May be involved in a Regulatory and/or Quintiles Initiative.
• Performs other tasks or assignments, as delegated by Regulatory management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Demonstrates comprehensive regulatory or technical area of expertise
Good negotiating skills and the ability to identify and resolve issues, using flexible adaptable approach
Strong software and computer skills, including MS Office applications
Demonstrated skills in chairing small meetings
Ability to work on several projects, retaining quality and timelines and can prioritise workload with minimal supervision
Ability to propose revisions to SOPs or suggest process improvements for consideration

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Degree in life science-related discipline or professional equivalent plus at least 3 years relevant experience* or high school diploma plus at least 9+ years experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel may be required