Description
You will provide leadership within the Regulatory Affairs Labeling group and will be responsible for contributing to the process for the development and implementation of product labeling for both products in development and established products.The successful candidate will
- Interact with other cross functional roles in the delivery and management of labeling text
- Edit and maintain product labeling per area product lead instruction, including redlined and proposed labeling documents
- Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements
- Maintain accurate files of labeling change history and associated documents
- Be responsible for the processing and storage of Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs) and Labels, ensuring they are compliant to internal requirements for publishing
- Develop subject matter expertise, and ongoing development of labeling expertise
- Utilise analytical skills to review and develop appropriate content for local labeling documents based on core content
- Work within a framework of internal SOPs and working practices, and external regulatory requirements
- Support the use of relevant tools and technologies within the course of the label development and translation process
Essential experience
- 3-5 years in Regulatory, R&D, Quality or related area; 3 years in Regulatory preferred with experience in Labeling
- Working knowledge of EU labeling, ROW labeling experience desireable
- Knowledge of regional regulatory regulations and guidelines pertaining to labeling, and general regulatory experience, potentially gained in a country office environment
- Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation
- Excellent project management skills, and ability to plan and prioritise, working within specific deadlines
- Written and verbal communications clear and effective, fluency in English essential
- Good verbal and written communication skills in a second European language