1. Learning objective

In this session you should know what are regulatory affairs and its soft skills.

2. Video

3. Regulatory affairs

a. What is regulatory affairs?

in Wikipedia

The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. The most significant responsibility of a regulatory professional in an export company is to get a product successfully registered and approved by the health agency of the country like FDA (Food and Drug Administration) for USA, or EMA (European Medicines Agency) for Europe.

Regulatory professionals are employed in industry, government and academia and are involved with a wide range of products, including:

The regulatory professional's roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising and postmarket surveillance.

The role of regulatory affairs manager, regulatory professionals are responsible for (topra):

• Keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products
• Advising on legal and scientific restraints and requirements
• Collecting, collating and evaluating scientific data
• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned
• Giving strategic and technical advice at the highest level in their companies, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole
• Helping the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data.
• Additionally, the regulatory affairs department will often take part in the development of product marketing concepts and is commonly required to approve packaging and advertising before it is used commercially.

The most important KPI of regulatory affairs manager are:

• Number of registered medical device or IVD
• Time and effort to register a product in critical market
• Records to pass the quality management and technical documentation review
• The regulatory affairs manager acts as liaison between international authority or agency (or certified or notified body) and internal research and development department. The supporting departments are including but not limited to R&D,
• Project management
• Quality management
• Quality assurance
• Clinical affairs
• Sales and marketing
• Supply chain and logistic

Whom is regulatory affairs manager working with?

Below are illustrated counterparts with whom regulatory affairs manager is working.

The external outsourcing can depending on resource be:

·        consulting company

·        interim RA or project manager

·        distributor

·        testing lab 

b. 10 soft skills of regulatory affairs

Communication

You transfer regulatory task internally and externally. How to explain a complex task in a didactic way is never easy. With authority by deficiency replay you should use all kinds of communication tool (email, telephone, face to face meeting) to answer questions intelligently.

Multicultural

Especially in global registration you have to communicate with people from other culture. They might be creative, extroverts, active or structured, introverts and passive. Even among the same company people has different mentality with same language but dialect. Imagine how many counterparts will be worked with in a registration, how often.

SO respect the other ways to communicate, handle and solve problems is essential. You can build unexpected trust, joy and friendship. The regulatory results come automatically.



Strategical

You need strategy to mark a product in global markets. Based on working with sales, marketing and external recourse you have to find a prioritized market with unique product feature. The foundation to have a strategical plan of regulatory affairs is to understand the compliance and counterparts, not only CEO.

Leadership

In this field you don’t need to inspire people. However you might have some junior or intern. You should be a good example to share regulatory insights and delegate some routine jobs. Besides typical leading it is nowadays crucial to accept second opinion to reach the common goal.

Working at interface of internal R&D and external authority you should dictate as a conductor.

Interdisciplinary

You should have basic understanding of technical documentation. So the knowledge can be wide from hardware, software, product development to clinical affairs or special testing. A good RA manager can provide ideas how to assemble a document with good structure and understanding. Internally you have to talk with different departments with limited manpower. The more you talked technically, the quicker you might get the point of wished results.

Project management

Every registration depending on market is a short or long journey. You must have a planned project with budget, organized timeline, manpower. You should have a tool to check project approach, to align with project goal and manager a success project result. Responsibility is key character. As a project leader you have to take care of all steps carefully and follow the actions with deadline.

Time and Resource management

Normally you know the efforts of registration as RA manager. You should have a controlled time resource management. It means that project milestone is well defined by fulfilling regulatory tasks by exact colleague and within deadline. In some company you have additional project management to assist. RA manger plays also an active role.

Regulatory intelligence

You should be familiar with legal texts and regulatory update. It is easy to follow all regulations. However knowing the core of regulations to be complaint for authority and to optimize the safety and effectiveness of medical device should never be conflict. Before entering a market you should have a pre-market analytic matching company’s goal. After approval of products there are product design change, report of adverse event or recall and non-compliance of products in QM to handle.

Creativity

At project it runs not always smoothly. If you have to negotiate a trouble not planned during the registration, you should act creatively using all resources and oft make your own way. The key is to focus the most important things and to priorities e.g. registration in critical markets

Controlling

To mark a product in a country should be controlled from the start of planning the registration to final approval. You can have a regulator meeting with appropriate groups to report the project approach. When a mistake is recognized, be flexible to lead the path back to normal. At end of project, write a project summary which can be understood by all participants in projects, so this is a record to reproduce next registration with better KPI.

c. 5 RA metaphors

Be a student

DO you remember how hard working you are as student. If you are eager to new regulation and careful for upcoming deficiency like an exemplary student, you can achieve more regulatory credits. So fight for your credit or certification.

Be a cook

As cook you have to guarantee that at the end all customers (markets) are happy with your dish. From preparing source material to preparation and cook, you control that no mistake is happening. For the fancy dish of VIP customer (China, EU and US) markets you must have hands-on touch to master challenging part of results.

Be an event organizer

If you are organizing an event, you think about what to do. This is checklist in a typical project at regulatory affairs. You have to communicate each parties to play theirs well, as project review. You want to have fun for a nice event. It is compared to a huge market entry of precious product in China or in EU.

Be a F1 team leader

Regulatory affairs job is stressful and spirited like F1 team leader. You have many F1 drivers sprinting. You forward the tactic during the run and make all stops (mistakes) as short as possible. You are responsible for the whole competition and at the end you share success with the whole team.

Be a tracker

This is from all wished character. You can track all registration actions by whom, how and when. In 5 years you can trace the former technical documentation and reproduce change registration. This is never taken seriously after project, however for either head of RA or RA manager it is most important in this field.