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Regulatory Labelling Manager

2 months ago

Surrey, United Kingdom Proclinical Staffing Full time

Proclinical is seeking a dedicated and detail-oriented Regulatory Labelling Manager. The successful candidate will be responsible for preparing and updating labelling documents for nationally registered products in accordance with internal SOPs and external regulatory requirements. The role also involves acting as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labelling requirements and participating in intelligence sharing. This role will also play a key role in the use and development of global tools, technologies and processes to support label development, submission and approval with a particular focus on digital solutions.

Responsibilities:

Maintain system management for labelling activities including Global Document Management System and approved labelling tracking system.Provide ad hoc support for labelling deliverables and perform quality checks of labelling text.Contribute to the completion of moderately complex projects under the direction of more senior labelling managers.Utilize regulatory knowledge to produce non-complex LPDs, LLDs, and PLDs.Identify incremental improvements to labelling-related processes and systems.Utilize regulatory labelling expertise to review, develop and deliver labelling documents for submission to the Regulatory Authorities across markets/regions.Support provision of other deliverables within the scope of ILG responsibilities.Assist with labelling data analysis and create or enhance SharePoint web pages.Prepare responses to inquiries from colleagues in response to inspection activities and regulatory agency questions. Key Skills and Requirements:Basic knowledge/understanding of the principles and concepts of labelling.Proficiency in the use of systems consistent with business expectations.Fluent in English; multi-language skills are advantageous.Clear and effective written and verbal communications.Proven knowledge working with structured data. For example in enterprise databases, MS Excel, MS SharePoint, and/or MS Access.Life sciences, pharmacy graduate or equivalent; or equivalent relevant professional experience.Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.Attention to detail and problem-solving skills.Proven technical aptitude and ability to quickly learn new software and regulations.Experience in registration associated with development, maintenance, and commercialization activities within Regulatory Affairs.Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label.Knowledge of global/regional regulatory guidelines and requirements.
Interested or know someone who might be? Reach out to Caitlin Siljeur using the following:

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If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.