ASSOCIATE DIRECTOR REGULATORY OPS- Labeling CCDS-RSI Compliance and Process Job

Job description

ASSOCIATE DIRECTOR REGULATORY OPS
- Labeling CCDS-RSI Compliance and Process-0000104DDescriptionJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc., is currently recruiting for an Associate Director, Global Regulatory Operations – Labeling CCDS-RSI Compliance and Process . This position will be located in Maidenhead, UK.Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
The Associate Director, Global Regulatory Operations
- Labeling will be responsible for: Responsibility for Global Regulatory Operations Labeling – CCDS-RSI Compliance and Process; Includes CCDS-RSI operational and content expertise and oversight, implementation of common standards and tracking enablement; Alignment and partnership for development and customization activities for tools used for labeling development and lifecycle; Support for emergent global requirements; Assist with organizing, providing and ensuring training on Labeling process & technology for labeling user communities, internal teams, vendors, partners, affiliates, and stakeholders; Ensure development and maintenance of templates for labeling documents for emergent functions; End to end labeling compliance oversight (through submission of local label); Vision for future state capability of implementation of labeling oversight; Inspection and Audit oversight for labeling; CAP management and SOP coordination in concert with labeling peers and management; Training coordination for rollout of new processes; Ensure vendor training and onboarding for Global Labeling Management; inclusive of contract coordination; End to end coordination of labeling requirements with labeling peers and management; Thought leadership for implementation of optimal proofreading, review and approval and tracking of CCDS-RSI lifecycle; Design process which includes capability for local labeling implementation via SOP and WI development; Oversight and improvement of tracking tools (CCDS/RSI trackers) in concert with GRA tools (ARIS register, etc.); Ability to design and oversee an outsourced business model with optimal structure and tracking activity to completion; Oversight for outsource partners in multiple regions (team size significant and will involve multiple levels of workers.)QualificationsBachelor’s degree with 8+ years related pharmaceutical regulatory experience (or closely related function) is required. LEAN thinking and/or Change Agent experience preferred. Cross Sector Experience preferred. Demonstrated ability to design (and conceptualize) business processes required. Prior experience designing business processes in support labeling document management and tracking for labeling submissions preferred. Ability to design training and business aids to support business tools and processes preferred. Ability to ensure alignment of business processes and technical systems required to support CCDS Lifecycle management or other relevant compliance systems preferred. Expert in MS Office Suite required. Ability to identify and understand complex problems and recommend common, effective compliant solutions within a global organization required. Ability to identify and scope future state requirements to drive continual business process improvement and compliance required. Ability to work within a global matrix environment independently to ensure deliverables and timelines are met required. Ability to work across global environments successfully required. Excellent verbal and written skills are required. Prior experience in training and presenting preferred. Ability to effectively communicate at all levels of the organization and with global vendors required. Travel may be required as needed 20-25%, both domestic and international.
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Primary Location:Europe/Middle East/Africa-United Kingdom-England-MaidenheadOrganization: J & J Consumer Inc. (6101)Job Function: Regulatory Compliance