Regulatory Affairs Officer II - LCM
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.
Preparation of submissions including Marketing Authorization Transfer, CMC variation filling, initial MAA filling, labelling updates, CMC authoring and \ or updates as required.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
4-5 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)
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
Broad experience in preparing international dossiers including APAC regulatory requirements.
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 5 year’s relevant experience*
(*or combination of education, training and experience)
5 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.