at Rose International Inc. in Deerfield, Illinois, United States
Job Description
Date Posted: 09/08/2023 Hiring Organization: Rose International Position Number: 449724 Job Title: Regulatory Affairs Manager Job Location: Deerfield, IL, USA, 60015 Employment Type: Temporary Estimated Duration (In Weeks): 56 Skills/Attributes: Pharmaceutical, Regulatory AffairsJob Description
- **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Company: Rose International
Job Title: Regulatory Affairs Manager – CCDS/CCSI/RSI Lead
Job ID: 23846
Duration: 12 Months
Location: Deerfield, IL 60015
Industry: Medical Device/Pharmaceutical
Summary:
Your role:
• 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
• Bachelor’s 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.
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
