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Regulatory Affairs Manager

Riverwoods, IL 60015

Posted: 03/04/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 599517 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience amd ranges between $60-68/hr
 
Manager, Regulatory Affairs - CCDS/CCSI/RSI Lead

The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.

This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved. What you'll be doing
  • Accountable for all operational aspects including owning, creating and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.
  • Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership.
  • Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers.
  • Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.
  • Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements.
  • Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labeling and content management, including requirements, use cases and translations.
  • Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation.
  • Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.

What you'll bring
  • Bachelors degree in pharmacy, biochemistry or similar science related field preferred.
  • Minimum 5 years of pharmaceutical regulatory or regulated content management (e.g., labeling, or Company Core Data Sheets) experience.
  • Ability to run sophisticated projects and timelines in a matrix team environment.
  • Strong project management and organizational skills.
  • Ability to independently identify compliance risks and raise when necessary.
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About Riverwoods, IL

Ready to find your dream job in the vibrant community of Riverwoods, Illinois? Nestled in the beautiful Lake County, Riverwoods offers a unique blend of city amenities and small-town charm, making it an ideal location for career growth and personal fulfillment. From the stunning landscapes of the Ryerson Woods Forest Preserve to the thriving arts scene at the Deer Path Art League Gallery, this area has something for everyone. Explore job opportunities near iconic landmarks like the Ravinia Festival, indulge in the local cuisine, and catch a show at the Marriott Theatre. Join us in Riverwoods and discover the perfect balance between work and play as you embark on a fulfilling career journey. Start your job search today and unlock endless possibilities in this enchanting region!

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