Manager, Regulatory Global Labeling

• Lead the development, review, and management of US, EU, and International labeling for a product in development and commercial products
• Assess and manage labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages
• Ensure appropriate labeling strategies are communicated to project teams
• Ensure labeling is compliant with core labeling and local regulations
• Ensure labeling is accurate and of the highest quality
• Support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status
• Lead the assigned product labeling teams (PLTs) and support labeling positions
• Collaborate with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams
• Prepare labeling content based on source documents such as CSRs, regulatory requirements and other reference documents
• Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content
• Facilitate the review and approval process within the product labeling teams
• Manage approved labels in a label management database/corporate system
• Maintain knowledge of current rules and regulations governing global labeling activities
• Receive and collate labeling text from labeling team members and manage labeling content and revision control
• Review and approve artwork and change control related to labeling activities
• Support launch and/or release of revised labeling into production
• Prepare labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS
• Represent REG GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs)
• Participate on Product Core Teams and present strategic global labeling issues to Regulatory Management
• Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices
• Document control and distribution of product labels
• Project management role of logistical activities and delivering labeling documents within agreed timeframes
• Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheets
• Prepare and manage International labeling including tracking differences in local labels to the CCDS
• Manage translations and address discrepancies with local partners and linguistic experts
• Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes in local product information
• Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings
• Assess country-specific deviations from the CCDS
• Provide RA input to Periodic Safety Update Report (PSUR) and Annual Reports
• Support the development of artwork and approve new or revised labeling to be implemented into production
• Approve all change requests for revised labeling
• Provide Supply Chain and QA guidance on labeling implementation requirements
• Support first launch into new markets
• Contribute to global labeling management and continuous improvement initiatives
• Review and comment on emerging internal and external guidelines and regulations
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes

• 4-6 years experience in the biopharmaceutical/biotechnology industry, or 2-4 years with Advanced Degree (Masters, PhD, MD)
• 2+ years in Regulatory Affairs
• Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities
• US and/or EU Labeling experience minimally required and core labeling experience highly desired
• Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements
• Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content
• Experience with E2E global labeling processes and management of Company Core Data Sheets
• Experience in review process, standards, and industry best practice pertaining to labeling
• Strong scientific background and/or experience
• Working knowledge of medical terminology and drug safety
• Proven project management, leading teams from multiple functional areas
• Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling
• Experienced processing and assessing translations of labeling a plus
• Excellent verbal and written communication skills
• strong technical writing and presentation skills
• Must be able to work as a team member and independently
• Strong attention to details required and high-quality work
• Fluency in English as business language, additional languages advantageous
• Ability to travel (up to 15%) for industry conferences or other business meetings
• Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines
• Minimum requirements BS or MS with requisite experience and demonstrated capability
• Science or medical background desirable

International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable

• Discretionary annual bonus
• Discretionary stock-based long-term incentives
• Paid time off
• Company-sponsored medical, dental, vision, and life insurance plans