Regulatory Affairs Officer I
- Regulatory Affairs
- 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
Key words phrases are:
Post Approval; Variation; Renewal; Referral; change control assessment; regulatory strategy; team work.
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.