The field of regulatory affairs is full of technicalities surrounding the development of pharmaceutical products. Regulatory professionals are responsible for liaising with pharmaceutical companies, manufacturers and global regulatory authorities to navigate the process of approving new products for the market.
While engaging with others in the global healthcare field, regulatory affairs professionals also work on developing important documentation that details pharmaceutical guidelines and reports. Both verbal and written communication are essential skills for anyone looking to lead scientific conversations that determine the approval of new products on the healthcare market. If you’re training in the field of regulatory affairs, discover some tips for communicating effectively on the job.
Determine the Goals of Communication
Regulatory affairs professionals will often have to communicate with pharmaceutical companies at different stages of the drug development process. At each stage, it’s important to clarify the goals of communication and the regulatory expectations so that each side can work on streamlining the review process. That way, any issues that arise can be addressed and resolved quickly.
Through strong communication, those in careers in regulatory affairs may aim to:
- Relay changes in legislation or regulations
- Clarify the regulatory expectations for a new product
- Provide scientific advice during product development
- Discuss any deficiencies in the development process
In each case, communicating in a transparent and timely manner will help you to support the research, testing and approval process of new pharmaceutical products.
Know Your Audience for Careers in Regulatory Affairs
As a regulatory affairs professional, you will be working with many people across different departments. These include:
- Regulatory authorities e.g. Health Canada and the FDA
- Marketing departments
- Manufacturing sites
Effective communication is needed for establishing a productive relationship with each of these stakeholders. You’ll be responsible for taking the lead in relaying information on regulatory updates, legislation and guidance documents. In each case, speaking clearly and precisely will help you get your message across.
Depending on your audience, you should be able to report key scientific information in simple and comprehensible terms. Avoid confusion by focusing on the basic facts and leaving out extraneous details. That way, you can be sure that pharmaceutical companies understand the regulations in place and make informed decisions throughout the manufacturing possess. After all, clear communication on regulatory issues will help with the timely and cost-effective development of new products on the market.
Written Communication Should Be Technical and Precise
Technical writing is another important part of scientific communication in the field of regulatory affairs. After earning your regulatory affairs certification, you should be prepared to write and review documents that will be used to guide pharmaceutical practices in the manufacturing and post-approval stages. Most regulatory documents are highly structured and technical. To communicate written information effectively, you’ll need to compile scientific information into a precise format to produce a document that conforms with legal requirements.
Students in the regulatory affairs program at AAPS will develop these communication skills through a course in Technical Writing and Scientific Communication. This course covers the
essential elements of developing Standard Operating Procedures (SOP), Records of Training, Batch documents, Change Control, Stability documents, as well as deviation and investigation reports. In the process, you’ll understand the value of clear communication in influencing the practices of the pharmaceutical field.
Are you exploring regulatory affairs programs?
Start your career with training at the Academy of Applied Pharmaceutical Sciences today!