Regulatory Affairs: Global Lead of Labelling - Home Based!

NonStop Recruitment ,
London, Greater London
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Job Description

My client, a solid company in the pharma pond, is looking for an experienced Global Lead of Labeling Regulatory Affairs. Luckily, they're a very flexible consultancy and are willing to let you work almost entirely from home if you're the right person! Specific activities include the following: * Accountable for the initial creation and relevant updates to labeling documents for the assigned product portfolio. * Guiding the Labeling Team to develop and maintain labeling documents including Core Data Sheets (CDS), Core Safety Information (CSI) United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized, National Procedures, and their associated Patient Labeling Documents. * Guiding and advising the Labeling Team on internal labeling guidelines and policies and to raise awareness of important factors to consider while revising the label. * To keep up to date with labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and to advise the Labeling Team accordingly. * Has a key role in identifying the downstream impact once the core documents are updated and communicate the same to the labeling team contributors and make sure that all the changes to the Core documents have been implemented globally. * To advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help the team in developing labeling text. * Leading the Labeling Team throughout the entire process, from the decision to update a labeling document (CDS/USPI/SPC) through notification to stakeholders to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. * Communicating the clear targets and prioritization plans, ensuring that Labeling Teams are aware of the agency/internal timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal compliance and external regulatory deadlines. * Serving as primary point of contact from labeling to Labeling Teams (e.g. A contributor from Regulatory, Safety, Medical, Clinical and Clinical Overview author) and will provide day-to-day direction to supporting team so that labeling and decision documents can be prepared and managed as required. * Key role in communicating and guiding the updates to country level labeling documents with responsible stakeholders. * Explore, Evaluate and implement efficient methods to meet the quality deliverables well within the internal and External timelines. * Proven project management skills with good attention to details, ability to negotiate, influence with problem solving capability and good written and verbal communication skills. * Capable of handling the labeling documents of Pharmaceuticals, biologics and consumer health products. Skills Required: * Excellent Communication Skills * Attention to detail and strong project management skills * Ability to multitask and prioritize competing agendas * Good organizational skills. * Excellent business collaboration/interpersonal skills * Ability to work under deadlines and fast paced work environment. * Understanding of global Labeling requirements and regulations * Computer literacy required in Microsoft Office Products such as Word, Excel and Outlook Profile : * 7-10+ years of RA experience of which at least 5 in labeling/post-marketing * Native/fluent level English * Motivated to work as a consultant (ask me for more info on what's like) * People management experience is a plus Are you interested? Get in touch with me: - Michael van Hooft - m.hooft@nonstopconsulting.com - +32 28 91 98 99

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