Regulatory

The Role of the Regulatory Project Manager

Today’s environment is becoming increasingly more complex, and one person cannot effectively undertake all aspects of a role. As such, companies are hiring Project Managers who are responsible for the regulatory process.

The role of the Project Manager is to analyse the process and ‘chunk down’ the entire process into different components, eg literature review, request for additional information from head office, review of in-house scientific material, and collation of information. They then determine who is the best person to undertake each task – often it is not just one person who can complete all the tasks effectively. Also a number of the tasks can be delegated to more junior people (eg collation, literature reviews), to more senior people (answering specific regulatory questions) or outsourced to contractors (eg for a medical opinion, or to a consultant). In today’s rapidly changing healthcare environment it can’t all be done in-house, therefore companies need a flexible labour force – ie contractors to work on a variety of short and medium term assignments so that business objectives are being met.

These skills include:

• the ability to follow guidelines and effectively communicate scientific data in a structured manner;
• the ability to source company data (by building effective relationships with head office);
• the ability to respond to regulatory questions in a timely and accurate manner
• knowledge of all regulatory, import and reimbursement regulations
• an understanding of the wider commercial picture – ie the importance to the company of registering products and maintaining the registration status.
• A thorough understanding of the role of safety in relation to customers – what safety issues are our customers facing with our products and what are we doing about it.

The Regulatory Project Manager needs an overall understanding of all the regulatory requirements and issues, but importantly they need the interpersonal skills to make requests of others to get the job done. The Regulatory Project Manager is not necessarily the most senior person in the department but they are the person with the responsibility to get the project moving along. They need to be able to get everyone to deliver on the agreed milestones.

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