Jobs at Pharmaceutical Product Development
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PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 19,000 professionals worldwide
SR Compliance Specialist job at Pharmaceutical Product Development (PPD)
Summarized Purpose:
Executes quality and compliance strategies and initiatives across the organization. Manages the tracking and reporting of quality and compliance activities. Maintains tools and materials, serves as project lead, and provides mentoring and expertise to advance the vision of the department.
Essential Functions:
• Liaise with lab operations and lab QA to provide support, mentoring, training regarding SOP system, standards, and process
• Provide back-up SOP administration for PTO coverage and high volume
• Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities.
• Leads quality and compliance processes and ensures appropriate execution and completion.
• Leads smaller projects and/or some process/quality improvement initiatives.
• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
Job application procedure
Use the link(s) below to apply on company website.
• SR Compliance Specialist - GXP/GLP
Regulatory Affairs Director job at Pharmaceutical Product Development (PPD)
Regulatory Affairs Director(All Levels) - Toxicology Regulatory Advising
In this role, you will conduct strategic planning and nonclinical program management to enable successful development of small molecules and biologics in stages of development throughout the product lifecycle. You will feel confident providing nonclinical regulatory advice and executing projects while acting as liaison with internal and external clients.
What are the essential functions of the role?
• Responsible for developing and implementing nonclinical (pharmacology/toxicology) strategy and submission plans for assigned projects/products, together with clinical, pharmacokinetics, and bioanalytical colleague
• Provide consultation to clients on the design and management of nonclinical development programs from early discovery though regulatory submission for client program
• Identify required nonclinical studies for regulatory submissions and ensure the nonclinical program supports the manufacturing program and the intended clinical program
• Provide nonclinical advising and meeting support for successful interactions with global regulatory authorities
• Prepare/review pre-meeting packages (e.g., pre-IND and Scientific Advice briefing documents) and defend nonclinical programs to regulatory agencies
• Prepare/review pharmacology/toxicology sections of submission
• Review and analyze nonclinical data
• Provide consulting support to assist clients with placement and oversight of GLP and non-GLP studies at preclinical CRO
• Provide toxicology support for CMC activities (such as impurity and excipient evaluations and risk assessments for extractable/leachable programs)
Job application procedure
Use the link(s) below to apply on company website.
• Regulatory Affairs Director(All Levels) - Toxicology Regulatory Advising
SR Compliance Specialist job at Pharmaceutical Product Development (PPD)
Summarized Purpose:
Executes quality and compliance strategies and initiatives across the organization. Manages the tracking and reporting of quality and compliance activities. Maintains tools and materials, serves as project lead, and provides mentoring and expertise to advance the vision of the department.
Essential Functions:
• Liaise with lab operations and lab QA to provide support, mentoring, training regarding SOP system, standards, and process
• Provide back-up SOP administration for PTO coverage and high volume
• Researches and addresses issues, tracks metrics and maintains reports and documentation related to quality and compliance activities.
• Leads quality and compliance processes and ensures appropriate execution and completion.
• Leads smaller projects and/or some process/quality improvement initiatives.
• Communicates with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents).
Job application procedure
Use the link(s) below to apply on company website.
• SR Compliance Specialist - GXP/GLP
Regulatory Affairs Director job at Pharmaceutical Product Development (PPD)
Regulatory Affairs Director(All Levels) - Toxicology Regulatory Advising
In this role, you will conduct strategic planning and nonclinical program management to enable successful development of small molecules and biologics in stages of development throughout the product lifecycle. You will feel confident providing nonclinical regulatory advice and executing projects while acting as liaison with internal and external clients.
What are the essential functions of the role?
• Responsible for developing and implementing nonclinical (pharmacology/toxicology) strategy and submission plans for assigned projects/products, together with clinical, pharmacokinetics, and bioanalytical colleague
• Provide consultation to clients on the design and management of nonclinical development programs from early discovery though regulatory submission for client program
• Identify required nonclinical studies for regulatory submissions and ensure the nonclinical program supports the manufacturing program and the intended clinical program
• Provide nonclinical advising and meeting support for successful interactions with global regulatory authorities
• Prepare/review pre-meeting packages (e.g., pre-IND and Scientific Advice briefing documents) and defend nonclinical programs to regulatory agencies
• Prepare/review pharmacology/toxicology sections of submission
• Review and analyze nonclinical data
• Provide consulting support to assist clients with placement and oversight of GLP and non-GLP studies at preclinical CRO
• Provide toxicology support for CMC activities (such as impurity and excipient evaluations and risk assessments for extractable/leachable programs)
Job application procedure
Use the link(s) below to apply on company website.
• Regulatory Affairs Director(All Levels) - Toxicology Regulatory Advising
Job Info
Job Category: Several Jobs in one Advert jobs in Kenya
Job Type: Full-time
Deadline of this Job: 29 August 2022
Duty Station: Several
Posted: 15-08-2022
No of Jobs: 2
Start Publishing: 15-08-2022
Stop Publishing (Put date of 2030): 15-08-2065
Apply Now
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