The demand for regulatory affairs (RA) professionals is clearly evident across the pharma industry, consultancy companies, clinical research organizations, and regulatory agencies. As I was deciding on my career transition from being a laboratory scientist to a regulatory affairs specialist, I wanted to know what the skills needed across the regulatory affairs function. In no particular order, I have highlighted 6 essential skills that are currently demanded from a RA professional.
#1 Regulatory knowledge
A degree in any field of science will probably be good for many entry-level jobs in regulatory affairs. But to become an RA specialist, the theoretical knowledge of legislation governing medical products and the understanding of the technicality involved in regulatory submission would be an added advantage. Nowadays, RA professionals are expected to understand the health product sector and how drugs are being developed.
#2 Critical thinking
Keeping close track of regulatory changes and interpreting their implications on the drug development and authorization process is part and parcel of life in regulatory affairs. RA professionals need to be able to synthesize complex information and convert it into a comprehensible manner, especially during a project team meeting.
#3 Writing skills
Be prepared to write and review documents that can be hundreds of pages long. Also be prepared to support due diligence reviews, review of protocols, reports, and all types of regulatory documentation with regards to quality, safety, and efficacy. While most regulatory documents are highly structured templates, it still requires a certain amount of linguistic skills to combine subject matter knowledge and information from a spectrum of regulatory guidelines in order to come up with a document that is in conformance with legal requirements.
#4 Oral communication
Speaking clearly and persuasively in all possible situations. RA professionals sometimes function as a representative to both internal and external parties. Hence, being an effective communicator may come in handy in establishing relationships with regulatory authorities, the marketing departments, manufacturing sites, and other relevant technical functions. Sometimes, fluency in another language is often considered an asset.
#5 Organizing skills
RA professionals have to manage a wide range of tasks from advising to coordinating application procedures for the approval of medical products. They must be detail-oriented and able to develop realistic action plans as well as prioritize work activities – without these, there are bound to be difficulties in keeping up with all the tasks.
#6 Business skills
It becomes increasingly vital for RA professionals to also develop business skills and be able to integrate regulatory knowledge into business strategy. At the higher level of the career ladder, RA professionals have to exhibit sound judgment in finance, marketing, and policy as well as making timely regulatory intelligence, guidance, and strategy for the company.
Regulatory Affairs Professionals: 6 Essential Skills
The demand for regulatory affairs (RA) professionals is clearly evident across the pharma industry, consultancy companies, clinical research organizations, and regulatory agencies. As I was deciding on my career transition from being a laboratory scientist to a regulatory affairs specialist, I wanted to know what the skills needed across the regulatory affairs function. In no particular order, I have highlighted 6 essential skills that are currently demanded from a RA professional.
#1 Regulatory knowledge
A degree in any field of science will probably be good for many entry-level jobs in regulatory affairs. But to become an RA specialist, the theoretical knowledge of legislation governing medical products and the understanding of the technicality involved in regulatory submission would be an added advantage. Nowadays, RA professionals are expected to understand the health product sector and how drugs are being developed.
#2 Critical thinking
Keeping close track of regulatory changes and interpreting their implications on the drug development and authorization process is part and parcel of life in regulatory affairs. RA professionals need to be able to synthesize complex information and convert it into a comprehensible manner, especially during a project team meeting.
#3 Writing skills
Be prepared to write and review documents that can be hundreds of pages long. Also be prepared to support due diligence reviews, review of protocols, reports, and all types of regulatory documentation with regards to quality, safety, and efficacy. While most regulatory documents are highly structured templates, it still requires a certain amount of linguistic skills to combine subject matter knowledge and information from a spectrum of regulatory guidelines in order to come up with a document that is in conformance with legal requirements.
#4 Oral communication
Speaking clearly and persuasively in all possible situations. RA professionals sometimes function as a representative to both internal and external parties. Hence, being an effective communicator may come in handy in establishing relationships with regulatory authorities, the marketing departments, manufacturing sites, and other relevant technical functions. Sometimes, fluency in another language is often considered an asset.
#5 Organizing skills
RA professionals have to manage a wide range of tasks from advising to coordinating application procedures for the approval of medical products. They must be detail-oriented and able to develop realistic action plans as well as prioritize work activities – without these, there are bound to be difficulties in keeping up with all the tasks.
#6 Business skills
It becomes increasingly vital for RA professionals to also develop business skills and be able to integrate regulatory knowledge into business strategy. At the higher level of the career ladder, RA professionals have to exhibit sound judgment in finance, marketing, and policy as well as making timely regulatory intelligence, guidance, and strategy for the company.
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