Regulatory affairs (RA) is an integral part of the life sciences industry, bridging the gap between pharmaceutical, biotech, and medical device companies and regulatory bodies. For those considering a career in this field or looking to advance, understanding the right entry points, necessary skills, and emerging trends is essential. In this article, we delve into the advice provided by Andrew Willis, a seasoned expert in regulatory affairs, who shares his journey, insights, and tips for professionals at various stages of their careers.

Why Enter Regulatory Affairs?

Andrew Willis’s journey into regulatory affairs began unexpectedly, like many others in the industry. He started his career in pharmaceutical quality assurance before moving into regulatory affairs through opportunities that arose during his work in data management and development. Over his 37-year career, Andrew accumulated vast experience, transitioning from technical roles to strategic positions. His deep understanding of regulatory affairs now spans clinical, non-clinical, and CMC (Chemistry, Manufacturing, and Controls) domains.

Key Takeaway:
Career Diversification: Andrew’s diverse experience, from working as a chemist to his current role in advanced therapies, shows that regulatory affairs professionals benefit greatly from a broad knowledge base. Understanding different aspects of drug development can provide a solid foundation for strategic roles in regulatory science.

How to Get Started in Regulatory Affairs

A common question among aspiring professionals is how to enter the regulatory affairs field. Andrew states, regulatory affairs is an interdisciplinary field where experience from clinical research, chemistry, or manufacturing can serve as a valuable foundation.

Recommended Pathways:
Education and Training: Entry into regulatory affairs often comes after professionals gain experience in areas like clinical research or CMC. Introductory courses on regulatory affairs, such as those offered by Educo Life Sciences, are useful but should ideally be taken after gaining some hands-on experience. Andrew suggests taking such courses six to twelve months after entering the workforce.
Transferrable Skills: One of the most important skill sets for regulatory affairs professionals is the ability to interpret and present data clearly. Regulatory affairs is not just about compliance but also about creating linkages across various disciplines, such as chemistry and clinical research.

Key Takeaway:
Breadth of Knowledge: Entry-level positions often require analytical and organisational skills. An understanding of data interpretation and project management is crucial for success in regulatory roles.

The Changing Landscape of Regulatory Affairs

Over the past few decades, the regulatory affairs landscape has evolved significantly. From how drugs are developed to how clinical trials are conducted, change has been driven by technological advancements and shifting societal expectations.

Key Industry Changes:
Inclusivity in Drug Development: Traditionally, drugs were designed with men as the primary demographic. Now, however, regulatory frameworks are more inclusive, considering diverse populations, including women, children, and other underrepresented groups in clinical trials.
Technological Advancements: The introduction of mRNA technologies during the COVID-19 pandemic exemplifies how rapidly the field is evolving. Technologies like CAR T-cell therapies and monoclonal antibodies are revolutionising the treatment of diseases, particularly in oncology.

Key Takeaway:
Adaptability: Regulatory professionals must stay current with emerging scientific advancements and regulatory frameworks. Continuous learning is essential to remain competitive in this dynamic industry.

Transitioning to Biotech and Advanced Therapies

With increasing focus on advanced therapies, such as cell and gene therapies, many professionals are transitioning from traditional small molecule work to more complex biologics. Andrew, who has successfully made this transition, offers key insights into the skills needed for this shift.

Tips for Transitioning:
Fundamentals Matter: A solid understanding of core scientific principles remains vital, even when working with advanced technologies. Regulatory professionals transitioning to biologics or advanced therapies should focus on learning the fundamentals of quality control, manufacturing processes, and clinical linkages.
Mastering Complex Systems: Moving into advanced therapies requires a deep knowledge of how products interact with the body, from immunogenicity to biodistribution. Regulatory professionals should be prepared to dive deep into these complex areas to ensure compliance and product efficacy.

Key Takeaway:
Balancing Complexity: Whether working on small molecules or advanced therapies, the emphasis on quality and control systems remains constant. Mastering these areas early in your career will ease the transition into more specialised fields.

Advice for New and Experienced Regulatory Professionals

For those starting out or looking to grow in regulatory affairs, Andrew emphasises the importance of an open mind and a willingness to engage with all areas of the business. Success in regulatory affairs is not about memorising guidelines, but about understanding the “why” behind them and being able to communicate effectively across departments.

Top Tips for Success:
1. Communication Skills: Effective communication is key in regulatory affairs. Professionals must be able to convey complex scientific concepts to non-experts, such as finance or commercial teams. This requires both scientific literacy and business acumen.
2. Commercial Awareness: Regulatory professionals must also understand the commercial implications of their work. A deep understanding of the market and the business’s goals will help you align regulatory strategies with broader company objectives.
3. Continuous Learning: Regulatory guidelines evolve, as do scientific and technological advancements. Keeping up with industry trends through continuous professional development is crucial.

Key Takeaway:
Holistic Approach: A successful career in regulatory affairs requires more than technical knowledge. Professionals should cultivate strong interpersonal, business, and project management skills.

Future Growth Areas in Regulatory Affairs

Looking forward, several exciting areas of growth are expected to shape regulatory affairs in the coming decade. From connected health to combination therapies, regulatory professionals will need to adapt to these innovations.

Emerging Trends:
Connected Health: As healthcare becomes increasingly digital, there is a growing emphasis on monitoring patients in real-time through devices and apps. Regulatory professionals will need to navigate the intersection of drugs and digital health technologies.
Combination Products: The integration of devices with drugs is another growing area. Regulatory professionals will need to develop expertise in both drug development and device regulations to manage combination products effectively.
Advanced Therapies: With advances in cell and gene therapies, regulatory professionals must keep up with evolving requirements and ensure compliance with highly complex and novel treatment mechanisms.

Key Takeaway:
Future-Proofing Skills: To remain competitive, regulatory professionals should focus on developing expertise in digital health, combination products, and advanced therapeutic approaches.

Conclusion

A career in regulatory affairs offers dynamic opportunities for growth, learning, and impact. Whether you’re starting out or looking to transition into advanced therapies, the advice and insights from seasoned professionals like Andrew Willis provide invaluable guidance. The regulatory landscape is constantly evolving, and success lies in adapting, staying informed, and cultivating a broad skill set that spans science, business, and communication.
For those willing to embrace these challenges, regulatory affairs is a rewarding and fulfilling career path in the life sciences.

Watch the full interview here: