Regulatory competencies

Samantha Alsbury, TOPRA's head of professional development, meets with regulatory affairs experts in summer 2017 to discuss feedback to TOPRA's Competency Framework, a "blueprint" for performance within the regulatory affairs profession.

Competencies are the skills, knowledge and behaviours that are required for you to do your job in regulatory affairs. As innovation occurs, it is important that regulatory professionals stay relevant and have the necessary skills and competencies to make substantive contributions to their organisations. The following article outlines what TOPRA believes are the competencies needed for regulatory professionals working in human medicines, medical devices, chemicals, food additives, pesticides and veterinary medicines. The article also discusses the evolution of the Regulatory Affairs Competency Framework and its significance.


ARTICLE: Promoting excellence in the regulatory affairs profession: a competency framework

 Regulatory Affairs Competency Framework
  Strategy
Competencies related to assessing information – by using an analytical thought process – and achieving a defensible conclusion
   

 
   
Communication
Competencies related to communicating with diverse populations through verbal, written and non-verbal means
   Business and Organisational Awareness
Competencies related to the understanding of the business and/or regulatory agency’s authority, structure and activities
   Technical
Competencies related to the regulatory oversight of healthcare products development and commercialisation
     
   
Core
Competencies that cut across all domains
       
 Establishing
  • Identify relevant law, regulations, and guidance documents covering pre- and/or post-market requirements for healthcare products
  • Collect data relevant to the essential regulatory question, issue, or problem
  • Identify factors leading to regulatory recommendations.
 
  • Co-author basic regulatory documents and reports
  • Use appropriate questions to verify complete understanding
  • Recognise the importance of negotiation skills.
 
  • Explain the role of a regulatory agency, their authority, structure, and activities
  • Explain the ethical behaviour expectations of working in the regulated industry and/or for governmental agencies
  • Recognise and respect confidentiality and comply with relevant codes of conduct
  • Recognise the meaning and significance of conflicts of interest
  • Ensure personal compliance with relevant quality standards   Explain the role of regulatory professionals and their interrelationships with other functions in the organisation.
 
  • Complete low-risk regulatory assignments under appropriate supervision
  • Explain the interrelationship between law, regulation and guidance.
 
  • Explain the importance of integrity while conducting work duties
  • Use a systematic approach to accomplish assigned tasks
  • Prioritise work to meet timelines
  • Explain the importance of working as a team and operate effectively as a member of a multi-disciplinary team.
                   
 Consolidating
  • Contribute to the development of regulatory recommendations and decisions
  • Recognise potential regulatory issues, solutions, and opportunities   Identify the underlying processes and principles for developing product claims.
 
  • Use communication skills to transfer knowledge to entry-level employees
  • Review written correspondence from peers and entry-level employees
  • Employ effective technical and regulatory writing skills to author standard regulatory documents and reports
  • Explain complex technical regulatory issues into plain language to nontechnical audiences.
 
  • Identify the ethical principles and requirements related to the development of new healthcare products
  • Identify potential conflicts of interest and their significance.
 
  •  Create submissions and technical reports with limited oversight
  • Identify gaps in the evidence base supporting submission
  • Apply technical expertise in multi-disciplinary teams
  • Explain key aspects of the healthcare product’s development process
  • Advise on risk -based approaches, as appropriate
  • Review labelling and advertising for regulatory compliance
  • Implement quality systems to support regulatory processes
  • Describe clinical development plans commonly used to determine safety and efficacy/effectiveness
  • Review regulatory submissions.
 
  • Explain the importance of adapting to the changing regulatory environment
  • Identify skills and abilities that allow a regulatory professional to represent the function effectively as a member of a multi-disciplinary team.
                   
 Driving
  • Develop regulatory strategies to bring new healthcare products to market that support business objectives and are in compliance with regulatory requirements
  • Apply lessons from the history of domestic and international regulatory and product requirements
  • Identify new regulatory trends that could affect future requirements
  • Explain the role of risk management in regulatory strategy and operation
  • Explain evidence-based decision-making in the assessment of benefit–risk of healthcare products.
 
  • Prepare and deliver effective presentations
  • Analyse communications from health authorities and respond appropriately
  • Explain relevant regulatory issues clearly.
 
  • Manage regulatory plans for complex projects
  • Appraise the chance of regulatory success in bringing a new healthcare product to the market
  • Evaluate the global healthcare environment and its potential impact on the organisation.
 
  • Identify and interpret laws, regulations, and guidance documents for domestic and international agencies relevant to the development and commercialisation of healthcare products
  • Describe the rationale of regulations related to healthcare products
  • Lead regulatory activities for major projects
  • Advise on the conduct of ethical safety, other nonclinical, and clinical studies according to international standards
  • Identify quality requirements for the development and post-market maintenance of healthcare products
  • Review the regulatory implications of the outcome of the analysis of quality, nonclinical and clinical data. 
 
  • Advise on requirements for healthcare product issues such as those that may require corrective and/ or preventive actions
  • Develop standard operating procedures (SOPs) and policies
  • Implement and appraise continuous performance improvements of personnel and/or processes
  • Mentor junior professionals
  • Develop negotiation strategies with regulatory agencies and/or the regulated industry
  • Develop leadership skills that inspire high performance within the regulatory environment.
                   
 Influencing
  • Explain implications and the consequences that emerge from proposed regulatory recommendations
  • Formulate defensible regulatory strategies and recommendations for complex issues
  • Predict the effect of changes to regulations, policies, or procedures
  • Explain data requirements to support product claims
  • Contribute to the development of new or revised legislation and guidance documents.
 
  • Formulate regulatory and public health information to obtain a desired outcome   Use effective communication skills for public speaking
  • Advocate organisational position to decision-makers
  • Effectively communicate the value of the regulatory profession to stakeholders
  • Review and approve inspection and audit communications.
 
  • Perform due diligence   Analyse regulatory guidelines, policies, and actions to determine potential business impact on the organisation
  • Assess regulatory impact 
    and risk, and develop risk management recommendations
  • Explain opportunities for alignment of business objectives with regulatory requirements
  • Manage organisational change.
 
  • Evaluate benefit–risk balance of healthcare products   Explain complex regulatory concepts such as the role of biomarkers and surrogate endpoints to address questions of efficacy/effectiveness and/or safety
  • Develop, select and implement systems to ensure compliance
  • Assess regulatory needs for pre- and post-marketing submissions.
 
  • Identify innovative approaches to changes needed in the regulatory environment
  • Advocate for necessary changes both internally and externally
  • Evaluate emerging issues of trends in the development and commercialisation of healthcare products for area of expertise and assess their regulatory impact and risk
  • Establish and maintain collaborative relationships with stakeholders
  • Effectively manage  resources
  • Devise novel approaches to regulatory challenges
  • Create and implement crisis management plans and procedures
  • Apply leadership that inspires high performance, regulatory compliance, and continuous improvement.