As a regulatory affairs (RA) professional, you are well aware the demand is evidently high across the pharmaceutical/medical industry. You are the bridge between the government, the industries, and the consumers/market.
Regulatory affairs career is a fast past focused journey which can allow you to have a quick progression up the ladder. Although, the work can be demanding, intense, involving writing and reviewing of thousands of pages, with the right set of skills it can become an excellent career to the passionate few.
What are those right set of skills?
- Develop your soft skills
This may be written or verbal communication. As a regulatory affairs professional you should provide clear and persuasive communication since you are the representor of both the internal and external parties.
An effective communicator allows for better establishment of relationships between manufacturing sites and regulatory authorities. Negotiation between the two in regard to time, money, resources is one of many essential skills a RA must have. Which can be developed through practise or committing to learning courses. Some of the best sites to extend such skills can be Coursera, Udemy, etc.
In addition, having excellent writing skills to produce and review documents which can be hundreds of pages long is essential. Regulatory documentation reviewed with regards to quality, safety, and efficacy.
- Regulatory knowledge
As a regulatory affair professional, having the theoretical knowledge on legislations is an added advantage. Technicality involved in regulatory submissions, governing guidelines, governing medical products to name a few. Regulatory affairs professional are expected to know about the health product sector and how the drugs are developed.
Therefore, keeping an updated check on regulatory changes, new drug development, authorization process is an added bonus. Some of the best way a RA professional can advantageously keep themselves updated is by following regulatory company social medias and signing up to company podcasts.
Regulatory company and authorities tend to provide a continuous update on essential points a RA needs to consider. From new drug development to new medical laws. This will not only keep you updated with regulatory knowledge but will also provide you with the best negotiation and communication skills. While also adding an upgrade to your critical thinking.
- Develop your business skills
Developing your business skills as a RA professional especially at a higher level of the career ladder is a must. As a RA your exhibiting sound judgement in marketing, finances, and other aspects of the business. All the while making timely regulatory guidelines and strategy for your company.
On the other hand, a RA professional needs to be organised. Climbing the social ladder will only increase responsibilities. Hence, developing your organizational skills to maintain a structured procedure for approving of medical products, prioritizing work activities with realistic actions plans will be the key.
Which can be developed through work placements. Regardless of the career level having a work placement with a senior will benefit you further. Learning is the key and learning from the ones who are already doing it will make it that much easier.
In conclusion, you should be an individual who has a key passion for details while enjoying the nature of science and medicine. The steps in progressing and climbing the RA career ladder are easy but demanding. Remember practise doesn’t just make perfect. Practise make permanence.
In addition to this, your authorities will also have newsletters. Subscribing to these will give you more of a detailed description to the new regulations and developments. For the ones that prefer to watch and listen to new regulations and developments. Look out for regional conferences and authority webinars. GCC Regulatory affairs pharma summit is one that happens every year.