What is Regulatory Affairs?
Regulatory Affairs is an essential function within the pharmaceutical and healthcare industries. The role of the Regulatory Affairs function is to ensure that all developed products are safe and effective for use. The term “products” in this sense encompasses a wide range of commodities which include pharmaceuticals, medical devices, cosmetics and chemicals/biocides.
A Regulatory Affairs role will vary depending on the level of seniority. However, a few examples of what a role within this sector could entail are set out below:
- Ensuring all developed products comply with regulations
- Preparing dossiers and technical files for submissions
- Managing the submission through and any post-marketing activities i.e. post-market surveillance/remediation
- Communicating with regulatory bodies
- Gathering, analysing and evaluating key information
Typical Regulatory Affairs roles
Typical roles within the Regulatory Affairs sector are:
- Regulatory Affairs Associate
- Regulatory Affairs Manager
- Regulatory Affairs Consultant
- Regulatory Affairs Director / Head of
How can you progress your Regulatory Affairs Career?
If you are looking to progress your career within Regulatory Affairs you will need to have excellent communication skills, a keen interest in learning and great attention to detail in your work.
In addition to these characteristics, you will need to complete additional duties to take your career to the next level:
- Gain mentoring experience (senior-level positions)
If you are looking to move into a senior-level position, it is recommended that you gain mentoring experience. As you climb up the hierarchical ladder, the more responsibilities you will be given, and this will include sharing your knowledge and best practice with junior level candidates. It’s important to have the necessary skills to effectively communicate your knowledge and experience to trainees; enabling them to become proficient within their role.
- Stakeholder management experience
Regulatory Affairs professionals are essentially the bridge between employers, their products and the regulatory bodies. As a result, candidates need to be able to communicate effectively with key stakeholders and develop positive relationships. Gathering this type of experience will only come via direct interactions with stakeholders. However, your knowledge and experiences will grow over time.
- The Organisation for Professionals in Regulatory Affairs (TOPRA) certification
TOPRA is the professional membership organisation which represents and supports individuals working within Regulatory Affairs. TOPRA also provides CPD certifications for professionals working within the sector. This can be beneficial for your career progression as it can improve your capabilities and help you realise your career goals much quicker.
- Sandwich placements
A sandwich placement is a work experience opportunity for university students. Essentially, this opportunity allows a student to work in a specific industry for a set period. This enables you to gain exposure to your chosen career and apply your knowledge and skills to a real work environment.
What are the barriers to a career in Regulatory Affairs?
There are several obstacles candidates may need to overcome to enter the industry:
- A Life Sciences degree is a mandatory requirement to enter the Regulatory Affairs sector for most companies.
- There is a lot of competition within the industry itself. As a result, not all candidates are successful in their application.
- Lack of product experience can hinder your chances to enter the industry.
Can you transition into the Regulatory Affairs sector without previous experience?
If you are looking to transition into a role within Regulatory Affairs, it is highly recommended that you have experience within a related industry i.e. quality assurance, quality control, compliance etc. This enables candidates to gather practical experience in drug development and gain a better understanding of all associated processes involved.
Typical Regulatory Affairs career progression options
Typical career progression opportunities within Regulatory Affairs could look like:
- Regulatory Officer/ Executive / Associate
- Senior Associate
- Senior Manager
- Senior Director
- Head of Department
- Vice President
A career within Regulatory Affairs can be a rewarding one. In addition, if you’re passionate about science and drug development you’ll gain a lot of exposure and insight into the full lifecycle of the products. If you possess these key attributes mentioned previously and are passionate about the industry, a career within this versatile sector may be ideal for you.
If you are looking to progress your career in Regulatory Affairs or would like an informal chat to discuss your career progression opportunities, our specialist consultants can help - get in touch with them here. Alternatively, you can view all our current vacancies within this sector on our Regulatory Affairs Page.