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Our client is a Pharmaceutical company that develops and commercializes innovative therapies. They currently have a requirement for an EU Regulatory Operations Manager.
The Manager is responsible for independently performing multiple activities in support of global submission and Regulatory Operations initiatives. Applies technical proficiency and attention to detail in submission timeline negotiation and management, “troubleshooting”, as well as the ability to interpret and execute various submission types. This individual would also participate on Regulatory cross-functional representative of the Regulatory Operations function in the EU. Provides key input to business process development.
• Responsible for the management and compilation of EU Regulatory Submission Components and activities (Including CTAs/ MAAs, etc)
• Develops and updates the master content outline for specific submissions by working with EU/US Regulatory Affairs strategy, Regulatory CMC, Medical Writing and other functional submission team representatives
• Coordinates the receipt of finalized documents from contributing authoring functions.
• Collects and/or creates administrative submission documents
• Electronic submission experience relevant to eCTD submissions
• Strong project management skills
• Demonstrates a working knowledge of electronic document management systems and publishing technologies
• Comprehensive understanding of pharmaceutical business and R&D organization
• Excellent understanding of structure of reports and submission documents
• Strong coordination experience with both US and EU submissions and understanding of Regulatory Agency requirements (EU)
• Able to provide some leadership on a cross-functional team and work effectively in a matrix environment
PREFERRED EDUCATION AND EXPERIENCE:
• B.S. (or equivalent) and extensive years of relevant work experience
• Hands on experience with publishing/EU submissions in the pharmaceutical industry
• Strong knowledge and understanding of EU regulatory authorities
• Fluent spoken and written English mandatory; French and German desired
Mark.firstname.lastname@example.org +44 (0)203 1890180