Life Sciences

Regulatory affairs is an all-female task at Cerbios-Pharma

In its series of interviews with women in the pharmaceutical industry, LSKH asked the all- female CerbiosPharma S.A. Regulatory Affairs team about their goals in science.

The Cerbios Regulatory Affairs team, headed by Paola Alfano, Director of Regulatory Affairs, is focused on supporting customers in obtaining and maintaining the registration of the pharmaceutical products containing the Cerbios Group’s active pharmaceutical ingredients. They act as a liaison between worldwide health authorities and the company, and between the company and its customers.

“Strong technical skills are crucial for success in this role,” stated Paola Alfano, “but developing a regulatory strategy for global GMP compliance and dossier submissions also requires a focus on soft skills. We need to stay constantly updated on the latest national and international regulations and guidelines. Then, we advise the company on how to best interpret the rules, ensuring flexibility and tailoring them to the specific market and development stage of each product”.

LSKH: We wanted to start off our talk with Cerbios RA chatting about gender stereotypes that, because of our cultural and family backgrounds, seem to still discourage women from pursuing a career in science.

Q. What about the Gender Gap?

A. “Personally, I do not believe in the concept of gendered subjects,” said Aline Piani Giussani, Senior Regulatory Affairs Specialist at Cerbios. “I grew up with a mother in the service industry and a father in pharmaceuticals,” she says. “Yet, my mom mowed the lawn and my dad cooked. My family never imposed limitations based on gender. I had the freedom to choose, always with my parents’ support. I want to raise my children the same way.”

Aline continued, challenging stereotypes: “People often assume women prefer humanities and men like science. But my son enjoys humanities and my daughter studies science! It proves we can defy stereotypes”.

Géraldine Alberti, Junior Specialist at Cerbios, echoes this sentiment. “My journey in pharmaceuticals began in childhood,” she says. “I was fortunate to have a role model – a woman who thrived in STEM, a field perhaps even tougher back then, when women’s voices struggled to be heard. Her stories sparked my interest in science. My family always supported my choices and freedom, allowing me to pursue a scientific career.”

LSKH: Having an open family is a great resource, but having a mentor during university and the early working years can really help young women to build their confidence and motivation to pursue a scientific career.

Géraldine continued: “During my journey, I’ve had the opportunity to meet and be inspired by many people. Each one offered a valuable piece of the puzzle that shaped me”.

Pascale Passera, Senior Regulatory Affairs Specialist at Cerbios, added: “In high school, my chemistry teacher inspired five students, including myself, to pursue chemistry or biochemistry. Strong curiosity and passion for your chosen subject are crucial in university. The rest will naturally follow, no matter the field”.

Ilaria Galli, an intern at Cerbios since March, chimed in: “Recently, Paola Alfano offered me the chance to join this amazing team of women, who have achieved their dreams, ambitious goals and a respectable social status. It’s an honour to be part of it,” Ilaria continued, “and I hope it’s just the beginning of a long journey in the fascinating world of science”.

LSKH: However, there are still some residual stereotypes and prejudices in the STEM reality.

Géraldine elaborated: “Growing up, I never thought being a woman in science was unusual. However, once in the field, you encounter lingering stereotypes. While these categorisations still exist, I believe how we approach and address them is changing. During my time as an undergrad, I unfortunately witnessed comments against female biology students. One professor, known for his interactive lectures, once exclaimed in a second-year class, ‘Ah, you’re a woman, you probably won’t get this right’. These remarks, when processed correctly, fuel your determination to prove them wrong and expose their outdated and illogical basis. The constant pressure to demonstrate competence can be draining, though.”

Pascale partially agrees: “In my 25+ years of experience, I’ve mostly encountered a gender-neutral approach. My only concern is that motherhood is sometimes seen as a sacrifice, not a contribution to the company and society, especially regarding new generations. When parents can instill basic trust in the next generation, they create valuable and well-rounded individuals”.

LSKH: But the gender gap is just one of the challenges women face. Women often have to balance work demands with the responsibilities of caring for their families, which can be a difficult task.

Claudia Piodi, Senior Regulatory Affairs Specialist at Cerbios, wholeheartedly agrees. “Balancing work and family life can be challenging,” she says. “From personal experience, flexible remote working is a powerful tool for better time management. Working from home eliminates the daily commute, saving time and reducing stress – both crucial for women juggling multiple responsibilities.”

Claudia continued: “The flexibility and peace of mind that come with flexible remote working can even improve focus and productivity on demanding tasks. Having the freedom to choose a work-from-home environment that suits your personal and professional needs is a game-changer for work-life balance. It leads to less stress, fewer distractions and overall well-being, ultimately resulting in higher quality work”.

LSKH: Despite the virtuous example of Cerbios and its Regulatory Affairs team, the reality is slightly different: according to the United Nations, which deals with education and culture, less than 30% of the world’s researchers are currently women.

Q. What can we do to change this trend?

A. Géraldine offers encouragement: “It’s not always easy, but everyone has something valuable to contribute. So go for it!” She adds, inspired by a quote: “To truly live you have to be brave, reckless, fearless, fragile. Dreamers. This applies to everyone, regardless of gender or profession.

Chase your dreams!”

Paola concludes, acknowledging progress and outlining solutions: “The current generation of young women seems more aware of following their passions and abilities, regardless of gender. However, there’s still work to be done to close the gap and encourage more women in science. As managers, we have a responsibility to dismantle biases that discourage girls from dreaming of scientific careers. We can support them through strong mentorship, soft skills development and creating networking opportunities.

“This is our chance to make a real difference!”