Katalyst CRO
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Manager Regulatory Affairs
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Katalyst CRO .
Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. 5 months ago Be among the first 25 applicants Join to apply for the
Manager Regulatory Affairs
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 role partnering with key business, functional, and business partners to ensure commercial objectives are achieved. Accountable for operational aspects including owning, creating, and maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes supporting therapeutic and combination products. Lead the development, approval, and ongoing compliance of product labeling content throughout the product lifecycle; track status and maintain documents in controlled workflows; lead reviews and manage approvals through governance by cross-functional leadership. Make decisions regarding patient safety signals, indications, risks, and other regulated content creation/modification triggers. Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving complex global and local labeling solutions in accordance with regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals. Participate in executing regulatory labeling and content strategies for new and existing products, monitoring, evaluating, and communicating regulatory requirements. Lead or support initiatives to standardize and enable processes in labeling and content management, including requirements, use cases, and translations. Deliver responses and solutions, and identify opportunities for quality improvement, including audits and risk mitigation. Perform gap analysis on regulated content management processes; design, develop, assess, improve, and maintain related global regulatory and quality processes and solutions. Requirements:
Bachelor's degree in pharmacy, biochemistry, or similar science-related field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management experience. Ability to manage sophisticated projects and timelines in a matrix environment. Strong project management and organizational skills. Ability to independently identify compliance risks and escalate when necessary. Additional Details:
Seniority level: Associate Employment type: Contract Job function: Legal Industry: Pharmaceutical Manufacturing
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Manager Regulatory Affairs
role at
Katalyst CRO .
Please read the information in this job post thoroughly to understand exactly what is expected of potential candidates. 5 months ago Be among the first 25 applicants Join to apply for the
Manager Regulatory Affairs
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 role partnering with key business, functional, and business partners to ensure commercial objectives are achieved. Accountable for operational aspects including owning, creating, and maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes supporting therapeutic and combination products. Lead the development, approval, and ongoing compliance of product labeling content throughout the product lifecycle; track status and maintain documents in controlled workflows; lead reviews and manage approvals through governance by cross-functional leadership. Make decisions regarding patient safety signals, indications, risks, and other regulated content creation/modification triggers. Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving complex global and local labeling solutions in accordance with regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals. Participate in executing regulatory labeling and content strategies for new and existing products, monitoring, evaluating, and communicating regulatory requirements. Lead or support initiatives to standardize and enable processes in labeling and content management, including requirements, use cases, and translations. Deliver responses and solutions, and identify opportunities for quality improvement, including audits and risk mitigation. Perform gap analysis on regulated content management processes; design, develop, assess, improve, and maintain related global regulatory and quality processes and solutions. Requirements:
Bachelor's degree in pharmacy, biochemistry, or similar science-related field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management experience. Ability to manage sophisticated projects and timelines in a matrix environment. Strong project management and organizational skills. Ability to independently identify compliance risks and escalate when necessary. Additional Details:
Seniority level: Associate Employment type: Contract Job function: Legal Industry: Pharmaceutical Manufacturing
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