Ensuring healthcare products for human and animal use are licensed before being sold or supplied.
Occupational Profile
Regulatory affairs is the role within an organization that ensures all medicines for human or veterinary use and medical devices are appropriately licensed before being sold or supplied. This licence is either:
- granted by the relevant competent authority (e.g. the UK Medicines and Healthcare Products Regulatory Agency or the European Medicines Agency) based on an evaluation of scientific data submitted by the supplier, or
- demonstrated by compliance with the appropriate laws through a system of conformity assessment, declaration of conformity and involvement of Notified Bodies (e.g. British Standards Institute)
The processes, data requirements and formats to present the data to obtain a licence are established in law. Regulatory affairs also update the licence particulars during the product’s lifecycle.
A Regulatory Affairs Specialist is responsible for developing and implementing strategies that allow a company to legally develop, manufacture, market and supply healthcare and/ or veterinary products. The role critically evaluates the evidence generated during the development and use of the product for its suitability to support obtaining and managing marketing authorizations, CE marks and approvals for clinical studies in line with legal requirements. This role may be performed within an organisation that may range in size from innovative SME businesses to major multinational companies. A Regulatory Affairs Specialist may also work within service companies offering consultancy support to manufacturers or in the relevant competent authorities or Notified Bodies where they will be assisting in the review and assessment of regulatory and technical dossiers prior to issuing a licence.
By meeting their responsibilities, a Regulatory Affairs Specialist takes a leading role to ensure products comply with the regulatory requirements to receive an initial licence for marketing. They also develop and manage the regulatory strategy that ensures further changes to the licenced product continue to meet the regulatory requirements. Failure to meet these responsibilities could result in the product either not getting to the market or the product having to be withdrawn from the market. This could result in significant financial, legal and reputational implications for the company and impacts the availability of healthcare products for patients or animals.
Depending on technical field e.g. human or animal pharmaceutical or medical device, key responsibilities of a Regulatory Affairs Specialist would include:
- Creating and implementing regulatory strategies in agreement with key stakeholders
- Carrying out research to create and contribute solutions to regulatory issues
- Project managing license applications to agreed targets
- Providing guidance on regulatory information and input across functional teams
- Preparing and delivering regulatory operational plans
- Being accountable for ensuring optimal interactions between stakeholders
- Complying with processes, data requirements and standards
- Mitigating and managing risks
- Using professional knowledge and judgement to evaluate data to determine its suitability for use and to identify gaps in the data provided
Job titles for this role may include;
- Regulatory Associate, Strategist, or Executive, Regulatory Affairs Manager, Regulatory Compliance Professional, Medical Device Competent Person.
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