Support the development of strategies to ensure medicinal products and services meet the requirement of regulation
Overview
This standard covers the competencies you need to provide information and guidance to meeting organisational compliance in the business and to ensure regulatory and site quality requirements are in place and in accordance to current best practices, including Good Manufacturing Practice (GMP) to maintain compliance.
You will be required to support and input to the development of strategies and systems to ensure products and services meet the requirements of the organisational compliance, appropriate regulatory, product licenses and internal and external procedures for carrying out operations within life science environments.
This standard has been developed for persons responsible for regulatory activities whilst working in the life science sector. You are responsible with other members of the regulatory and quality teams for ensuring that all operations and procedures are processed and maintained in line with appropriate data security, regulatory, site and product license requirements.
Performance criteria
You must be able to:
P1 identify and evaluate the regulatory and legislative activities required to meet the site operating, product license and marketing authority requirements
P2 support and input to the development and design of regulatory strategies for relevant product quality and safety activities
P3 support and input to the development of strategies for addressing risks and license issues
P4 coordinate, support and communicate the plans for implementing licensing activities for all relevant regulatory business areas
P5 monitor and maintain records on all change management related to regulatory changes to company processes and systems
P6 provide reports and documentation in line with an communication strategy with regulatory authorities
P7 evaluate and ensure the effective use of the reporting process and ensure appropriate audits are successfully completed
P8 review all relevant licensing agreements, communicating and recording compliance and non-compliance in the appropriate organisational record system
P9 review process to carry out the departmental checks in compliance with rules and regulations and other statutory requirements
P10 review and update departmental functions, including cost structures, manufacturing processes and stock management to ensure compliance with rules and regulations and other statutory requirements
P11 provide advice and support to the organisation in the application of product licensing and registration requirements
P12 provide information on regulatory and licensing needs to different businesses and stakeholders in a timely manner
P13 work with teams and individuals within the organisation to ensure all aspects of regulatory and compliance needs are effectively communicated
Knowledge and Understanding
You need to know and understand:
K1 the principles of strategic planning and what a strategic plan should cover principles of quality assurance, quality control and the distinction between them
K2 the legislation, statutory codes, standards, frameworks and guidance appropriate to the organisation's operations and activities
K3 your our own roles, responsibilities and accountabilities with their limits and responsibilities
K4 how internal and external influences may impact on the work of your organisation
K5 how to work and communicate with regulatory authorities, agencies, and other stakeholders to maintain site license requirements
K6 the use of the organisations risk management and assessment process and reporting systems
K7 the use evidence based research relating to product quality and provision of services within the framework of license requirements
K8 the principle of Good Manufacturing and Distribution Practices (GMP & GDP)
K9 how to recognise areas for improvement against regulations, standards and best practice (GMP & GDP)
K10 how to implement, monitor and evaluate systems, practices, policies and procedure
K11 organisational policies and practices for monitoring and maintaining health, safety and security in the work environment
K12 legal requirements, policies and procedures for the security and confidentiality of information
K13 how to record written information with accuracy, clarity, relevance, an appropriate level of detail