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, there are several extra duties you can undertake to help advance your career:

1. 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.
   
2. 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.  
   
3. 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.
   
4. 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:

1. A Life Sciences degree is a mandatory requirement to enter the Regulatory Affairs sector for most companies.
   
2. There is a lot of competition within the industry itself. As a result, not all candidates are successful in their application.
   
3. 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
• Manager
• Senior Manager
• Director
• Senior Director
• Head of Department
• Vice President

Conclusion

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.

Career Pathways in Regulatory Affairs

Posted 31 March 2020 | By Christine Guertin, MS, RAC 

This “how-to” article discusses career pathways in regulatory affairs. The author traces her career path as she grew from an administrative assistant to regulatory generalist to vice president and explores the critical skills she mastered along the way. The author covers necessary skill sets, the benefits of having a good mentor and the importance of taking chances, even at the risk of some failures.

Introduction

If, in 1999, when I was working as an administrative assistant for my first biotech company, had someone asked me what my career aspirations were, I would have had no reply. I knew I wanted to work somewhere in science. And I knew that I wanted my work to make a difference. Fast forward 20 years and I am a vice president of regulatory affairs and quality assurance and I am doing just that—working in science and helping to make a difference in peoples’ lives.

At the beginning, I had no idea how my career would evolve. However, I was fortunate enough to have a wonderful mentor who encouraged me to identify gaps in my CV and strive to fill them. She reasoned I would still be learning and improving while figuring out how I wanted to direct my career.

Reflecting on how building technical expertise supported my career, I am struck by the criticality of “soft skills” (as opposed to technical skills) in helping my career growth. While the career of any regulatory affairs professional is varied, with many paths one can take, in this article, I want to explore a sampling of critical technical and soft skills to be mastered during a career and under each title.

Individual Contributor
Administrative Assistant, Regulatory Associate, Senior Associate

At the start of any career in regulatory affairs, there must be a focus on gaining competency in key foundational knowledge. This includes learning about regulations and guidances and becoming familiar with the requirements of a “good practice” quality guidelines and regulations (GxP) environment. Early in my career, I dedicated effort to developing an understanding of the foundational US regulations and guidances. Under significant supervision, I began to learn to research US regulatory precedence, a critical skill upon which I still rely.

Advanced Individual Contributor
Manager, Senior Manager

In more advanced individual contributor roles, there is an expectation that an employee has mastered some basic technical competencies and can work more independently. This can be a great time to consider adding some depth of knowledge to complement the breadth of knowledge already obtained. During this career phase, I developed a specialty in pediatric drug development. I was fortunate that my interest in this area was aligned with needs at my company, so I had many hands-on opportunities to gain experience in both US and EU aspects of pediatric drug development. Ultimately, this expertise would become a springboard for accelerating my career. As I gained expertise, I was rewarded with opportunities to support the company’s most visible programs which, in turn, raised my profile to the highest levels of leadership at the company. To be successful, it is critical the right people in your organization know how you add value to the company. My pediatric specialization gave me that opportunity and I ran with it.

This career stage is also the perfect time to begin honing communication skills, which include aspects of both technical and soft skills. First and foremost, regulatory professionals are communicators. Consequently, we often find ourselves writing and editing documents for submission to health authorities. However, even more of our time is spent communicating through emails and participating in, and presenting at, meetings. Whether writing an annual report, drafting an email to internal management or creating slides for an internal presentation, it is critical to have the ability to succinctly express and support key messaging. I spent significant time learning to hone my message by editing emails and presentations carefully. On the soft skills side, I also learned how to filter appropriate levels of messaging to management. Management is bombarded with massive amounts of information, so I learned which issues were important to elevate, and which would be too detailed for them. As my communication skills improved, I was afforded many more opportunities to present to more senior levels of the company, which I leveraged into opportunities to further build my reputation as the pediatric subject matter expert.

Middle Manager
Associate Director, Director

As one’s career advances, it becomes increasingly important to expand your geographic knowledge or “footprint.” Once you have demonstrated an advanced knowledge of regulatory affairs in one region, it is time to better understand the general considerations necessary for developing a comprehensive Regulatory Development Plan. In my career, that began by supporting ex-US clinical studies as an individual contributor, but I also worked on study start up for large pivotal studies in many regions at this time. I worked with our team to learn about drug development pathways in other regions, including the European Union (EU), Japan, Canada and Latin America (LATAM). With technical skill comes a key soft skill—understanding how to lead a multi-cultural team. I attended a formal training to better understand Japanese cultural aspects, which are quite intricate. This training awakened my general cultural sensitivity, which allowed me to better lead internal development teams and participate more effectively in external international partnerships.

This career stage is also the prefect time to ensure you have experience across various stages of development. In my case, this meant filling a gap in my CV with respect to marketing applications. During this time, I led a Supplemental Investigational New Drug (sNDA) and two Investigational New Drugs (NDAs). With these applications, I completed work in all phases of drug development and learned critical collaboration skills with partner companies. I led labeling working group meetings between my company and our partner companies in France and Japan and successfully gained agreement on key core data sheet elements.

By this career stage, one has (hopefully) built enough knowledge and experience that you can comfortably trust your instincts. This was the time in my career when I learned to become comfortable with discomfort. I learned to trust my intuition and my ability to leverage my experience to make good decisions on complex issues. With this comfort came the ability to embrace opportunities to stretch outside my comfort zone. That confidence allowed me to capitalize on opportunities for growth, which accelerated my career.

Department Head
Senior Director, Vice President

When moving into a leadership position, the importance of identifying, hiring and supporting talent becomes more critical. You may have a function reporting to you outside of your area of expertise as I do. Not only am I the head of regulatory affairs, but i also lead quality assurance, pharmacovigilance operations, and medical writing, all areas where I have varying degrees of personal experience. Because of this, I am particularly vigilant about hiring staff. I spend significant time screening resumes and doing telephone screens. To be successful, I must be able to effectively spot talent and identify candidates who will fit into my company’s culture.

The ability and willingness to delegate is critical. The need to delegate amplifies the importance of hiring the right people for your organization. I must assess my team’s capabilities accurately and assign tasks they can successfully achieve. It also is critical to support them as needed, and that looks quite different depending on an employee’s strengths and experience. However, it is imperative to give employees opportunities to challenge themselves and grow while offering them a “safety net” from failure. Because others did this for me is a significant reason for enabling me to gain the competencies for supporting my career advancement. I am committed to doing the same for my employees.

I always thought being a leader demanded fearlessness; however, my thinking on this has shifted. I believe leadership requires the desire to be curious and ask difficult questions as well as the knowledge to assess risk and the courage to do things that make you fearful. There will be times when I stumble and fail, but I hope I can be kind to myself in those moments, pick myself up, dust myself off and persist. Those experiences, like all the others before it, some of which are described above, will help me continue building my toolbox and advance my career.

Conclusion

Building a career in regulatory affairs is all about gaining two skill sets: soft skills, such as expertise in communication and “technical” or hard skills, such as in-depth knowledge of drug development and related regulations and processes. It also helps to have a good mentor, to be willing to take chances, to develop an area of specialization, to be able to work outside of your comfort zone and, later, at the management levels, learn how to spot talent and help it to develop.

About the Author

Christine Guertin, MS, RAC, is the vice president of regulatory affairs and quality assurance at Curis, Inc. and has more than 20 years of regulatory experience in the pharmaceutical and biotech industries. Prior to Curis, she was the head of regulatory affairs at Synlogic. Previous positions include global regulatory lead positions with Array BioPharma where she successfully led the concurrent NDA submissions for BRAFTOVI® and MEKTOVI® and Takeda Pharmaceuticals (formerly Millennium Pharmaceuticals) where she led many early development programs and led and contributed to pediatric development programs including those for VELCADE® and ADCETRIS®. Guertin earned an MS in health product regulation from Regis College and RAPS certification in 2006. She can be contacted at cguertin@curis.com.