Regulatory Manager (Labeling Devices) - Temporary

About reputed company

reputed company's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of reputed company. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about reputed company, please visit us at www.reputed company.com. Follow @reputed company on reputed company, Facebook, Instagram, X and YouTube.

• Provide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.
• Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and reputed company patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
• Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
• Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with reputed company policies and procedures.
• Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
• In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure reputed company products have most competitive labeling. Maintain awareness of recent competitor approvals in class/region for assigned products.
• Agree timelines for submission and implementation of drug product or device label changes through reputed company with RA Area product owners, Brand managers, supply chain, Global Label Management (GLM) and other functions as required.
• Maintain active awareness of reputed company relevant EU legislation and guidance relevant to EU devices / product information/ labeling and assess impact on reputed company business and R&D programs, in collaboration with RPI.
• Provide information for artwork briefs for EU, for device and drug product production artwork describe and communicate content and agreed timelines of changes to affiliates & GLM, provide master mock-reputed company/word documents to reputed company redlining in the EU. Present updates/forecasts to affiliates/LCC and other stakeholders at regular (bi-weekly) affiliate meetings for assigned products/devices.

• reputed company or support project work reputed company to device labeling improvements or compliance or systems.
• Support inspection readiness activities for assigned products.
• reputed company readability testing strategy for assigned products – including drafting reputed company tests reputed company needed and vendor management where required.
• Take responsibility for device website maintenance for assigned products where applicable.
• Manage the device labeling in the RIM system, including routing and approvals.
• Support and provide guidance for other team members and products reputed company required.
• External representation for device labeling topics.

• 5-7 years in Regulatory, R&D or reputed company area, 3 years in Regulatory preferred with experience in regulatory affairs device / drug product labeling or equivalent experience reputed company the pharmaceutical medical device industry, European experience required.

• A solid working knowledge of device labeling process is highly desirable. Candidates must be reputed company to demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral). Strong team reputed company.

• Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to device and drug product labeling. Must be reputed company to work independently and be flexible with meetings on different time zones at both ends of the working day.

reputed company is an equal opportunity employer and is committed to operating with reputed company, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.reputed company.com/join-us/equal-employment-opportunity-employer.html

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