Katalyst Healthcares and Life Sciences
Regulatory Affairs Operations Specialist
Katalyst Healthcares and Life Sciences, South Plainfield, New Jersey, us, 07080
Responsibilities:
Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.Assist with preparing high quality US regulatory submissions required by local and federal agencies for client's products.Ensure that all submissions are prepared per established requirements and submitted within established timelines.Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.Contribute to the development and implementation of applicable work processes and instructions. Ensure they are kept up to date and implemented.Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Understand and monitor regulatory trends; understand and implement regulations and guidance.Interfaces with relevant stakeholder groups as needed to ensure compliance.Provide training for team members in assigned areas of responsibility.Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes.With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.Requirements:
Knowledge in relevant Regulatory Affairs areas.Ability to understand and anticipate regulatory trends.Knowledge and established understanding of regulatory legislation and requirements for the maintenance of veterinary products.Strong proficiency in supporting data maintenance and archival and retrieval of regulatory documentation in computerized systems.Strong experience creating detailed work instructions that align with Regulatory Authority and client's Corporate Regulations for streamlined processes.Regulatory Affairs or equivalent industry experience is requiredIntrapreneurial spirit while being rigorous and disciplined with compliance requirements.Demonstrated ability to successfully collaborate in a global organization and manage a full workload.Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities.Strong attention to detailMust exhibit good judgment, and ability to problem-solve issues in daily workAble to meet stringent time and quality demands.Self-motivated with a high degree of initiative, commitment and persistence.Well developed organizational capabilities.Strong team player who is collaborative with the mission of BI, but able to drive change.AAI CompetenciesAccountability: Taking ownership for decisions and actions.Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.Bachelor's degree, preferably in science, and 6 years related regulatory experience.
Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.Assist with preparing high quality US regulatory submissions required by local and federal agencies for client's products.Ensure that all submissions are prepared per established requirements and submitted within established timelines.Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.Contribute to the development and implementation of applicable work processes and instructions. Ensure they are kept up to date and implemented.Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas. Understand and monitor regulatory trends; understand and implement regulations and guidance.Interfaces with relevant stakeholder groups as needed to ensure compliance.Provide training for team members in assigned areas of responsibility.Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of client's products and processes.With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.Requirements:
Knowledge in relevant Regulatory Affairs areas.Ability to understand and anticipate regulatory trends.Knowledge and established understanding of regulatory legislation and requirements for the maintenance of veterinary products.Strong proficiency in supporting data maintenance and archival and retrieval of regulatory documentation in computerized systems.Strong experience creating detailed work instructions that align with Regulatory Authority and client's Corporate Regulations for streamlined processes.Regulatory Affairs or equivalent industry experience is requiredIntrapreneurial spirit while being rigorous and disciplined with compliance requirements.Demonstrated ability to successfully collaborate in a global organization and manage a full workload.Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities.Strong attention to detailMust exhibit good judgment, and ability to problem-solve issues in daily workAble to meet stringent time and quality demands.Self-motivated with a high degree of initiative, commitment and persistence.Well developed organizational capabilities.Strong team player who is collaborative with the mission of BI, but able to drive change.AAI CompetenciesAccountability: Taking ownership for decisions and actions.Agility: Quickly acting with an open mind to face internal and external circumstances. Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.Bachelor's degree, preferably in science, and 6 years related regulatory experience.