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 role is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. It is an individual contributor role that partners with key business, functional, and cross-functional partners to ensure commercial objectives are achieved.
Responsibilities
Own, create and/or maintain CCDS/CCSI/RSI documentation and deliver, maintain, and drive regulatory systems, databases, and labeling processes supporting 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 processes and systems workflows; lead reviews and governance by cross-functional executive and subject matter authority leadership.
Make decisions regarding patient safety signals, indications, risk, 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 and other regulated solutions in accordance with end-to-end regulated content, labeling processes, and commercial objectives; review 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; monitor, evaluate, and internally communicate new and existing applicable regulatory requirements.
Lead or support global technology, process, and solution initiatives to standardize and enable standard processes in labeling and content management, including requirements, use cases, and translations.
Deliver responses, solutions, and identify opportunities to improve based on quality initiatives, including audits and risk mitigation.
Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain 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 CCDS) 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 them when necessary.
Job details
Seniority level: Associate
Employment type: Contract
Job function: Legal
Industries: Pharmaceutical Manufacturing
Location and compensation: Broomfield, CO • $65,600 - $82,000
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This role is instrumental in the design, development, and maintenance of global regulatory processes and business solutions. It is an individual contributor role that partners with key business, functional, and cross-functional partners to ensure commercial objectives are achieved.
Responsibilities
Own, create and/or maintain CCDS/CCSI/RSI documentation and deliver, maintain, and drive regulatory systems, databases, and labeling processes supporting 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 processes and systems workflows; lead reviews and governance by cross-functional executive and subject matter authority leadership.
Make decisions regarding patient safety signals, indications, risk, 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 and other regulated solutions in accordance with end-to-end regulated content, labeling processes, and commercial objectives; review 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; monitor, evaluate, and internally communicate new and existing applicable regulatory requirements.
Lead or support global technology, process, and solution initiatives to standardize and enable standard processes in labeling and content management, including requirements, use cases, and translations.
Deliver responses, solutions, and identify opportunities to improve based on quality initiatives, including audits and risk mitigation.
Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain 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 CCDS) 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 them when necessary.
Job details
Seniority level: Associate
Employment type: Contract
Job function: Legal
Industries: Pharmaceutical Manufacturing
Location and compensation: Broomfield, CO • $65,600 - $82,000
#J-18808-Ljbffr