Insights
September / October 2024

Women in Pharma® Editorial: Empowering Women in Regulatory Affairs

Miriam Kremer-van Der Kamp
Women in Pharma® Editorial: Miriam Kremer-van der Kamp

In the dynamic realm of regulatory affairs, a significant transformation is unfolding—a movement that empowers women to assume pivotal roles in decision-making, policy formulation, and leadership.

Historically dominated by men, regulatory agencies are now evolving into inclusive and diverse entities, where women are making remarkable strides.

Women are reshaping regulatory policies, offering invaluable perspectives, and challenging long-standing norms. Central to this advocacy is the urgent call for greater representation of women in clinical trials. Women have been notably underrepresented in these critical research studies, leading to significant gaps in our understanding of treatment efficacy and safety, particularly across diverse genders and backgrounds.

The imperative for diverse representation is fundamental to ensuring that medical interventions are tailored to meet the needs of all patients. The COVID-19 pandemic starkly highlighted the critical necessity of including pregnant and breastfeeding women in medical research. Acknowledging the pivotal role women play in discerning the safety and effectiveness of treatments, stakeholders are uniting to bridge the gender gap in research studies. Esteemed regulatory bodies, such as the US Food and Drug Administration (FDA), are actively collaborating with industry partners to champion the inclusion of these vulnerable populations in clinical trials. Through concerted efforts, steps are being taken to rectify the historical exclusion of these groups, ensuring their safety and well-being through evidence-based treatments.

Despite persistent challenges, such as the gender pay gap and unconscious biases, the momentum for change is palpable. A new generation of un-yielding women is propelling us toward a future where diversity is the bedrock of progress. Embracing initiatives like Women in Pharma®, we stand as advocates for gender equality within regulatory agencies. We are optimistic about the transformative journey ahead, one where diverse voices resonate, policies are shaped inclusively, and innovation thrives.

Recent insights from the “Women in the Workplace” report1  shed light on the evolving corporate landscapes of America and Canada. Though women’s representation in executive positions has seen progress, the mid-tier pipeline remains a bottleneck, especially for women of color. The report dispels myths about women’s ambition, revealing that post-pandemic flexibility has fueled a resurgence of drive among women professionals.

Drawing from the report’s recommendations, companies can proactively bolster women’s representation. Tracking outcomes, empowering managers, addressing microaggressions, and fixing the “broken rung” hindering women’s advancement are pivotal actions for inclusive and equitable workplaces, where all talents can flourish.

The pharmaceutical industry, particularly within the Germany/Austria/Switzerland (D/A/CH) region, has witnessed a remarkable evolution. Robust investments in research and development, coupled with collaborative efforts between industry and academia, have propelled advancements. The region’s well-

established regulatory, exemplified by the Swiss Therapeutic Products Act of 2019,2  ensure meticulous testing of medications before reaching patients, which fosters trust and growth.

Acknowledging the value women bring to the workplace, governments in the D/A/CH region have spearheaded initiatives to foster diversity and inclusion. Gender quotas on boards of directors and funding for programs supporting women professionals have raised awareness of gender equality. As a result, companies actively seek female talent, acknowledging the undeniable benefits of a diverse workforce.

The evolving landscape of the pharmaceutical industry heralds the dawn of a new paradigm: The workforce of the future. This paradigm encompasses the evolving nature of work, emphasizing attributes like digital literacy, lifelong learning, adaptability, and emotional intelligence.

In the vibrant landscape of regulatory affairs, women are at the forefront of transformative change. Their stories of resilience, advocacy, and empowerment serve as beacons for a new era of inclusivity. As we collectively forge ahead, guided by the principles of diversity and equity, we pave the way for a brighter, more inclusive future for healthcare and beyond. It is a future where women, empowered and supported, lead the charge toward progress, innovation, and lasting change.

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  • 1McKinsey & Company and LeanIn.Org. “Women in the Workplace: 2023.” Report. https://www.mckinsey.com/~/media/mckinsey/featured%20insights/diversity%20and%20inclusion/women%20in%20the%20workplace%202023%20v2/women-in-the-workplace-2023-full-report.pdf?%5C=
  • 2The Federal Assembly of the Swiss Confederation. “Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA).” Updated 1 January 2019. www.fedlex.admin.ch/eli/cc/2001/422/en
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