Career Advice: Sophie’s Journey in CMC Regulatory Affairs

An interview with Educo Life Sciences Trainer Sophie Nageotte

In this interview, Sophie, an experienced professional in pharmaceutical regulatory affairs, shares her career journey, the evolution of the industry, and advice for those starting in the field. With over 22 years of experience, Sophie offers valuable insights for professionals interested in Chemistry, Manufacturing, and Controls (CMC) regulatory roles. This article summarises her thoughts on the industry’s changes, necessary skills, and the exciting future of pharmaceutical regulatory work.

 

Sophie’s Career Path

Sophie began her career as a chemical engineer and has spent over two decades working in the pharmaceutical industry. Starting as a Technical and Regulatory Affairs Associate at Laboratory Galderma, she was responsible for maintaining technical dossiers and managing the scale-up of clinical and industrial batches. After eight years, she transitioned to Bio Consumer Care, where she focused on CMC writing and overseeing the transfer of manufacturing sites.

After gaining experience in larger pharmaceutical firms, Sophie chose to work with smaller companies, participating in product registration and post-marketing variations. Eventually, she founded her own consultancy and has been freelancing for six years, working on regulatory dossiers and delivering professional training in various regulatory topics.

 

Entering the Pharmaceutical Industry

Sophie’s entry into the pharmaceutical industry was not pre-planned. After completing her studies, she was searching for a job in the Alps and came across an advertisement for a chemical engineer who spoke English. Having spent her final year studying in Manchester, Sophie was an ideal fit for the role. Although unfamiliar with regulatory work initially, she soon became engrossed in the field.

Her love for the regulatory aspect of pharmaceuticals developed as she learned about marketing authorisations and the technical elements involved. This blend of science and regulatory work kept her engaged, and she continued to build her career in the field.

 

Changes in the Industry

Sophie reflects on the significant changes in the regulatory landscape since she began working in 1998. At that time, regulatory requirements for post-marketing variations were relatively lax. For instance, she recalls instances where plant managers didn’t understand why regulatory approval was necessary for production changes.

Today, regulations are far stricter, and companies are required to have a deep understanding of why certain processes are used. There is a shift towards a more comprehensive approach, where understanding the reasons behind production methods and controls is essential, rather than simply relying on established practices.

 

Advice for Young Professionals

Sophie’s main piece of advice for young professionals entering the pharmaceutical industry is to never stop learning. She emphasises that working in regulatory affairs, particularly in CMC, requires a continuous learning process. Technologies and practices evolve, and professionals must stay up to date with the latest advancements.

She also highlights the importance of being flexible. In regulatory affairs, last-minute changes are common, and professionals need to adapt quickly without becoming frustrated. The ability to revise work and adjust to new information is a key skill in this field.

 

Learning and Development

When it comes to continuous learning, Sophie believes that a combination of methods is most effective. She stays informed by reading books, attending training courses, and even taking evening classes at universities. For example, about ten years ago, Sophie pursued a diploma in biotechnology to enhance her knowledge in the area, showing that even after many years in the industry, she continues to seek out opportunities to grow.

Learning from colleagues and industry experts is another important aspect of development. The exchange of ideas and experiences helps professionals stay current in their field.

 

Challenges in Biotechnology

Transitioning from chemical to biotechnology products posed a significant challenge for Sophie. Unlike chemical molecules, which are more straightforward, biotechnology involves much more complexity. Sophie admits that working in this area requires humility and an acceptance that there is always more to learn. Open-mindedness, flexibility, and creativity are crucial for finding solutions to the unique challenges presented by biotechnology.

Although biotechnology is an exciting field, Sophie stresses that it does not replace the need for small molecules, which remain essential for treating common ailments. The regulatory challenges for both biotechnology and small molecules will continue to provide ample opportunities for professionals in the field.

 

Key Skills for CMC Regulatory Professionals

In addition to technical knowledge, Sophie believes that soft skills are critical for success in CMC regulatory roles. Communication is particularly important, as regulatory professionals must work with various departments and individuals, each contributing different parts of the regulatory dossier. Flexibility is equally essential, as unexpected changes can occur at any stage of the regulatory process.

Speaking English, Sophie points out, is a must for non-native speakers working in regulatory affairs, given its status as the universal language of science and regulatory work. For those who are not fluent in English, Sophie suggests making it a priority, as it opens doors to working in global markets.

 

Pros and Cons of Working in Regulatory Affairs

One of the main advantages of working in regulatory affairs, according to Sophie, is the ability to see the entire production process, from the development of the drug substance to the post-market stage. This comprehensive view makes the work more interesting and rewarding.

However, there are also challenges. Last-minute changes, both from within the organisation and from regulatory authorities, can be frustrating. Furthermore, the lack of harmonisation in regulations across different countries adds complexity to the role, as professionals must stay updated on evolving regulations in each market.

 

The Future of CMC Regulatory Affairs

Looking ahead, Sophie sees exciting developments in CMC regulatory affairs. The industry is moving towards a new regulatory paradigm, where understanding the product and why certain processes are used is becoming more important. This shift applies not only to new products but also to those already on the market, where lost knowledge from decades ago may need to be rediscovered.

Although biotechnology is often seen as the future of pharmaceuticals, Sophie believes that small molecules will continue to play a crucial role. The regulatory landscape for small molecules will present its own challenges and opportunities in the years to come.

 

Conclusion

Sophie’s career in pharmaceutical regulatory affairs offers valuable insights for professionals at all stages of their careers. From the importance of continuous learning to the evolving challenges in biotechnology, her advice highlights the need for flexibility, adaptability, and a passion for science. For those considering a career in regulatory affairs, there is much to look forward to in this dynamic and ever-changing field.

 

Watch a snippet of the interview here:

 

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