Reg Affairs Officer 1
Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.
• Acts as a Regulatory Team member involved in projects, under the guidance of senior staff.
• Manages day-to-day workload in collaboration with senior staff, as appropriate.
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
• Actively participates with internal and external customers and communicates confidently in straightforward matters.
• Understands the Scope of Work, and deliverables for a given project.
• May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person.REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
· Preparation of relevant CTD (Common Technical Dossier) documents to support submissions (mainly Module 1), in collaboration with Technical/CMC/Labelling experts
· Quality review of technical/ regulatory documents
· Interaction with Regulatory Agencies (EU and/or National Agency)
· Regulatory strategy and determination of documentation requirements, timelines, budgets
· Revision/review of regulatory SOPs, as appropriate
· Project management experience - an advantage
· Ability to work to tight timelines and manage peaks in workload
· Good team player
· Good negotiating skills and the ability to identify and resolve issues
· Excellent verbal and written communication skills
· Excellent computer skills e.g. Word, Excel, data and document management systems
· Cultural awareness for global ways of working
· Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Degree in life science-related discipline or professional equivalent plus at least 2 year’s relevant experience*
(*or combination of education, training and experience)
• 2 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions.