Katalyst CRO
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Regulatory Affairs Manager
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Regulatory Affairs Manager
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Katalyst CRO 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. 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.
Responsibilities
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. 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.
Requirements:
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. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Regulatory Affairs Manager roles.
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Regulatory Affairs Manager
role at
Katalyst CRO Continue with Google Continue with Google 3 days ago Be among the first 25 applicants Join to apply for the
Regulatory Affairs Manager
role at
Katalyst CRO 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. 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.
Responsibilities
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. 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.
Requirements:
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. Seniority level
Seniority level
Associate Employment type
Employment type
Contract Job function
Job function
Legal Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Regulatory Affairs Manager roles.
Continue with Google Continue with Google Continue with Google Continue with Google Sr. Regulatory Affairs Specialist - SaMD/SiMD
Irvine, CA $83,898.06 - $120,000 4 weeks ago Senior Manager, Regulatory Affairs - Device (Onsite or Remote)
Irvine, CA $83,898.06 - $120,000.00 3 days ago Senior Manager, Regulatory Affairs - Device (Onsite or Remote)
Irvine, CA $121,000.00 - $230,000.00 5 hours ago Specialist - Premarket Regulatory Affairs
Irvine, CA $110,000.00 - $120,000.00 3 months ago Irvine, CA $86,000.00 - $120,000.00 11 hours ago Senior Manager, Regulatory Affairs - Device (Onsite or Remote)
East Irvine, CA $121,000.00 - $230,000.00 1 week ago Irvine, CA $123,000.00 - $174,000.00 2 weeks ago Regulatory Affairs and Compliance Analyst (Medicare)
Orange, CA $68,015.00 - $108,824.00 2 weeks ago Senior Specialist, Regulatory Affairs THV
Irvine, CA $90,000.00 - $127,000.00 1 week ago Senior Manager, Regulatory Affairs (Device)
Aliso Viejo, CA $160,000.00 - $180,000.00 4 weeks ago Westminster, CA $96,000.00 - $122,000.00 2 days ago AI & Data Manager - Life Sciences R&D Regulatory (Pharma)
Irvine, CA $106,500.00 - $202,500.00 3 days ago Associate Specialist- Post Market Regulatory Affairs
Regulatory Affairs Specialist III - Urology
Associate Specialist Premarket Regulatory Affairs
Sr. Associate II, Regulatory Affairs Strategy
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr