Katalyst CRO
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Regulatory Affairs Manager
role at
Katalyst CRO .
Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. Get AI-powered advice on this job and more exclusive features. 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 change control and labeling processes. This individual is instrumental in designing, developing, and maintaining global regulatory processes and business solutions. This is a key contributor who partners with business and functional teams to ensure objectives are met. Accountable for operational aspects including owning, creating, and maintaining CCDS/CCSI/RSI documentation, and managing 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; manage documentation in controlled workflows; oversee reviews and approvals by cross-functional leadership. Make decisions regarding patient safety signals, indications, risks, and content modifications. Support global implementation of CCDS/CCSI/RSI into country-specific labeling, developing and approving complex labeling solutions in line with regulatory and commercial objectives. Participate in executing regulatory labeling strategies for new and existing products, monitoring regulatory requirements. Lead or support initiatives to standardize labeling and content management processes, including requirements, use cases, and translations. Deliver responses and solutions, and identify opportunities for quality improvements, including audits and risk mitigation. Perform gap analysis on content management processes; design, develop, and improve related regulatory and quality processes and solutions. Requirements
Bachelor's degree in pharmacy, biochemistry, or a related science field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management experience. Ability to manage complex 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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Regulatory Affairs Manager
role at
Katalyst CRO .
Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. Get AI-powered advice on this job and more exclusive features. 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 change control and labeling processes. This individual is instrumental in designing, developing, and maintaining global regulatory processes and business solutions. This is a key contributor who partners with business and functional teams to ensure objectives are met. Accountable for operational aspects including owning, creating, and maintaining CCDS/CCSI/RSI documentation, and managing 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; manage documentation in controlled workflows; oversee reviews and approvals by cross-functional leadership. Make decisions regarding patient safety signals, indications, risks, and content modifications. Support global implementation of CCDS/CCSI/RSI into country-specific labeling, developing and approving complex labeling solutions in line with regulatory and commercial objectives. Participate in executing regulatory labeling strategies for new and existing products, monitoring regulatory requirements. Lead or support initiatives to standardize labeling and content management processes, including requirements, use cases, and translations. Deliver responses and solutions, and identify opportunities for quality improvements, including audits and risk mitigation. Perform gap analysis on content management processes; design, develop, and improve related regulatory and quality processes and solutions. Requirements
Bachelor's degree in pharmacy, biochemistry, or a related science field preferred. Minimum 5 years of pharmaceutical regulatory or regulated content management experience. Ability to manage complex 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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