Regulatory policy and regulatory intelligence
With many guidelines and requirements in place, regulatory professionals may be specialists in this role or incorporate it as part of their wider role. Regulatory Intelligence (RI) is continuously evolving in terms of how it is conducted, and different companies use different approaches to this function. In any case, RI is much more than just information sharing, it involves translation of the information into something that is meaningful to the business. This role is an opportunity to proactively shape the regulatory environment, often through trade associations, and to disseminate regulatory intelligence within an organisation. RI professionals may be involved in the following activities:
- Membership of trade associations and professional organisations helps to engage with and develop tactical/operational partnerships to enhance the building and sharing of intelligence
- Review of existing guidance/suggestions for new guidance documents, engaging with subject matter experts internally
- Issue position papers
- Coordinate engagement with external and internal stakeholders on research policy and regulatory issues
- Lead in monitoring and influencing the development of legislation and regulation
- Dissemination of regulatory intelligence via a company’s various internal communication routes
- Monitor regulatory publications in the therapeutic area and markets of interest and communicate these changes to the different functions (RA, R&D, Quality Assurance, etc)
- Conduct an impact analysis of the regulatory changes, turning regulatory information into intelligence, allowing better strategic decision making – the human element of RI is vital and contributes to the impact analysis and strategic elements rather than simply information gathering
- Ensure the company remains compliant with evolving regulatory requirements in the countries in which it operates – promote an intelligence culture that supports a targeted approach to compliance
- Support colleagues by responding to their ad hoc queries for clarifications on given regulatory topics
- Identify regulatory opportunities and contribute to the regulatory strategy
- Maintain the knowledge base of internal and external intelligence – as RI roles move towards policy influencing activities, having robust RI tools in place is essential
- Facilitate and lead presentations, discussions and forums up to senior management level, which provide intelligence and analysis on emerging trends and risks.
Depending on the size of the organisation, Regulatory Intelligence and Regulatory Policy can sit within the regulatory affairs department or be distinct functions.
CMC stands for Chemistry, Manufacturing and Controls. It includes but is not limited to activities related to:
- The chemistry of the product and its quality (drug substance, drug product, composition, dosage form, container closure system)
- Its manufacturing (manufacturing process, product supply, manufacturing site transfers)
- All changes in relation to the manufacture of the product, its quality that have a regulatory impact
- All changes triggered by new regulations regionally or locally that have an impact on the quality and/or the manufacturing process of the product
- Control of quality (in reference to USP, EP, JP).
CMC professionals have an active role in developing and endorsing global regulatory CMC strategies for portfolio or assigned projects/products for development projects or marketed products. They are involved in the following activities:
- In the case of products in development
- Plan/prepare/submit/review support for CMC elements of product dossiers including territory extensions (CTD Module 2.3 & Module 3)
- Prepare and maintain the CMC component of CTA/IND applications
- Interact/liaise with HAs on development CMC topics such as scientific advice interactions
- In the case of marketed products
- Undertake recurrent filings; annual reports
- Manage manufacturing site renewals (GMP)
- Input into the post-approval regulatory strategy in change control process of CMC changes and implement related gap analysis Response to HA Queries on CMC related aspects – US, EU and rest of world (ROW)
- Global regulatory CMC strategies and risk assessments for development projects and/or marketed products in collaboration with other parts of global regulatory affairs. This assures positive and collaborative relationships with CMC teams to achieve implementation of appropriate regulatory strategies.
The regulatory labelling and artwork roles are concerned with the packaging and labelling of pharmaceutical/medical devices products in accordance with regulations; principally the information printed on the outward packaging and inner leaflet, which contains important safety information and any adverse effects. A labelling specialist’s day-to-day activities may include:
- Generating core data information that companies ideally want to see in their labels in all markets
- Assisting in the preparation of new and revised US Product Information (USPI) and/or Summary of Products Characteristics (EU PI) and others throughout the product lifecycle and in support of all submission types
- Responsibility for the maintenance of database to track the history and version control of each product labelling
- Supporting implementation of improvements in quality, productivity, regulatory compliance, cost-effectiveness, and safety
- Supporting the development and the implementation of labelling changes
- Liaising with supply chain to ensure implementation of these labelling changes in a timely manner and in line with regulations
- Maintaining current knowledge of FDA, EMA (and other regional, local) regulations and guidances pertaining to labelling.
Regulatory operations – or RegOps as it is often known – specialises in systems, processes, data and regulatory submissions. RegOps professionals can often be classified into two areas: submissions and publishing; and information management.
RegOps is a progressive function with ambitions to standardise and harmonise regulatory data across industry. It has become a critical player in helping companies make efficient and well-informed business decisions to help bring drugs to patients more effectively. Its future role is in helping bring about a change in cross-company data standards/governance and leading a transformation to a more data-centric R&D organisation and regulatory network.
Within this role, regulatory professionals will be involved in multiple projects and tasks including:
- Regulatory dossier publishing – NDAs/MMAs and lifecycle submissions (CMC, Safety, Labelling)
- Regulatory system administration – management of systems for publishing, document content management, regulatory information management, labelling review, change control management, text verification, xEVMPD among others
- Project management of complex cross-functional projects
- Process improvement and compliance activities – corrective action and preventative action (CAPA) plans, design and execution of tailored internal audit and inspections programmes to ensure inspection-readiness and adhere to authorities’ compliance requirements
- Regulatory intelligence – guidance on the impact of new legislations, directives or guidelines and how they may impact company’s processes, systems, etc
- Cloud computing and digital transformation (ie, the use of digital technologies, such as automation, predictive analytics and artificial intelligence) is increasingly remodelling how regulatory operational activities are executed.
The regulatory landscape for medical devices has undergone major legislative changes in recent years with the introduction of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) in 2017.
Examples of devices that regulatory professionals may work with include:
- Implantable devices
- In Vitro Diagnostics (IVDs)
- Drug-Device Combination Products (DDCs)
- Radiology and Medical Imaging Devices
- Software as a Medical Device (SaMD)
- Hospital Equipment Dental devices
- Wound care devices.
As part of their day-to-day roles, medical device regulatory professionals may be involved with:
- Supporting the development and implementation of guidance and requirements for regulatory strategies for medical devices
- Assisting in the preparation of the labelling of the medical device and supporting the development and implementation of labelling changes
- Conducting risk management activities
- Implementing and maintaining a quality management system (QMS) throughout the lifecycle of the medical device
- Maintaining regulatory files including the technical file, design dossiers and post-market surveillance activities
- Liaising with other associated economic operators for the medical device concerned
- Liaising with critical suppliers for the medical device
- Performing vigilance activities, including complaints handling, incident reporting, field safety corrective actions and device recalls
- Reviewing and assessing design and process changes for any regulatory impact, and ensuring the technical file, clinical evaluation report and risk management file are kept up-to-date throughout the device lifecycle
- Managing inspections by NBs and CAs.
The animal health sector is much smaller than human medicine but it also offers a wealth of opportunities. Professionals with degrees in chemistry, pharmacy, biological sciences can easily enter the sector. There are plenty of career opportunities in big pharma, regulators, SMEs, consultants and CROs.
Veterinary medicinal products (VMPs) are regulated in much the same way as human medicines, but with important differences:
- Multiple species, from food-producing animals to pets
- Residues of VMPs in food (eg, meat, milk, eggs)
- No clinical trials directive
- No medical device regulation
- No biosimilar animal health products
- No dedicated pharmacovigilance regulation.