‘Inside Regulatory Affairs’ With Bayer Consumer Health’s Jenny Holmes

In this installment of HBW Insight’s “Inside Regulatory Affairs” series, Bayer Consumer Health’s global regulatory director, Jenny Holmes, describes how the job has changed in recent years to assume an enabling role for innovation.

Inside Regulatory Affairs - Jenny Holmes, Bayer Consumer Health
• Source: Citeline/Bayer Consumer Health/Shutterstock

HBW Insight is shining a spotlight on the work of regulatory affairs specialists operating in and supporting the consumer health and cosmetics industries. We are profiling this important role, hearing what a typical day involves and finding out what is top of mind for these individuals today. Look out for further installments in this series in HBW Insight over the coming weeks.

Once upon a time, regulatory teams were perceived as project “blockers,” consulted only at the end of the innovation process and seen as “mere enforcers of requirements,” according to Bayer Consumer Health’s Jenny Holmes.

Nowadays, however, regulatory teams have “evolved into strategic navigators and partners, integral to defining business strategies and outcomes for consumers,” says Holmes, who is Bayer Consumer Health’s global regulatory director.

“Rather than struggling for a seat at the table, the challenge now lies in prioritizing which tables to join, as our expertise is in high demand across the organization,” Holmes comments, in the latest instalment of HBW Insight’s series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries.

Q

What is a typical day in the life of a regulatory affairs professional?

A

In my experience as a regulatory professional in a fast-paced consumer health company, whilst it is a bit of a cliché, it is absolutely true that no two days are alike - every day presents new and unique challenges. Our expertise and skills are integral at every stage of a product's life cycle, as we strive to enhance consumers' access to self-care products and information. Navigating through complex regulatory frameworks globally, including those governing OTC medicines, food supplements, cosmetics, and medical devices, are a core part of our impact. The types of activities we may be involved in on a day to day also depend on what area of reg affairs you sit in – to illustrate let me touch on three areas:

In regulatory new product development (NPD) teams, we may contribute to the creation of concepts for new products and provide insights on regulatory pathway options. We collaborate with cross-functional teams to ensure the generation of data packages that meet global registration requirements and are also key in due diligence for in-licensing opportunities.

In the realm of life cycle management (LCM) for existing products, we focus on maintaining compliance and continuity of supply to consumers. This involves collaborating with supply colleagues on manufacturing process changes, assessing the impact of new ingredient requirements, and ensuring the latest product information is communicated through updated labeling.

In regulatory policy and intelligence (RPI), we work to prepare and build resilience while identifying new opportunities across the business, we work with experts across the organization, to anticipate and adapt to dynamic external environments. This could include utilizing AI to monitor authority updates or summarizing complex changes and their implications for non-technical audiences. We can be found participating in trade association meetings to discuss emerging legislation and also strategize our position on key policy topics for external advocacy.

Q

How has this role changed over time?

A

In the past the regulatory department were often consulted towards the end of a project, primarily for compliance sign-off. Regulatory teams were perceived as mere enforcers of requirements, struggling to secure a seat at the strategy planning table and being labeled as project “blockers.”

However, over time, there has been a significant shift in mindset and behaviors within regulatory teams and cross-functional colleagues. Great regulatory teams have evolved into strategic navigators and partners, integral to defining business strategies and outcomes for consumers. Bringing not only regulatory expertise but also deep insights into the science, products, and brands they oversee, alongside valuable competitor activity insights. Instead of solely focusing on limitations, they provide counter suggestions, innovative ideas, and engage in collaborative discussions to explore alternative options and trade-offs. This shift has elevated regulatory professionals from being perceived as a “service function” to being valued as key partners and enablers. Rather than struggling for a seat at the table, the challenge now lies in prioritizing which tables to join, as our expertise is in high demand across the organization.

Changes in technology and the shift to remote and hybrid working during the pandemic has opened up opportunities for talent in regulatory affairs that were not there previously. Professionals with diverse expertise and agile leadership skills in consumer health are always in high demand! Changes in ways of working has given individuals freedom to decide where they would choose to work, and take on new opportunities without being limited by geographic location. This flexibility allowed me take on a new opportunity leading to my current role in policy and intelligence and also support the development of a talented and diverse global regulatory team at Bayer's Consumer Health UK hub over the last few years.

Overall, the evolving role of regulatory affairs has empowered professionals to be proactive partners in driving business strategies, leveraging technology, and embracing a more inclusive and flexible work environment.

Q

What is currently keeping you up at night?

A

Less so keeping me up at night, but definitely front of mind is the following:

The rapid rate of change in our sector presents a significant challenge. Operating within a diverse regulatory landscape, spanning various classifications and regional or national legislation, requires navigating a complex environment.

The dynamic nature of the industry, with increasing rates of change, demands that regulatory professionals not only stay abreast of current regulations but also focus on anticipating future developments and opportunities.

Scrutiny on ingredients and materials, coupled with the growing global concern for environmental health and sustainability, adds another layer of complexity. It is crucial to ensure that changes are driven by credible science to avoid disproportionate restrictions that could impact product availability for consumers and strain healthcare systems. Staying ahead of these changes and their potential consequences is a top priority. (Also see "WHO Resolution Targets OTC Antimicrobials, Industry Insists Problem Is Rx Misuse" - HBW Insight, 13 August, 2024.)

The vital role of consumer health products in public health is another area of focus. Self-care products play a crucial role in providing solutions for individuals and families to manage their health and wellbeing. As waiting lists for medical appointments rise and resources are strained, it’s more important than ever that self-treatable conditions are encouraged to be managed with self-care products, allowing medical professionals to focus time and money on more complex healthcare needs. Conversely, in regions where healthcare access is limited, self-care products are often the only means of supporting health and well-being. It is not enough for these products to be available; consumers must also be equipped with the knowledge of how and when to use them independently. Socioeconomic studies highlighting the value of self-care underscore the importance of our work, but also emphasize the need for further action in this area. (Also see "Self-Care Saving Taxpayers $120bn Per Year, Could Increase To $180bn By 2030" - HBW Insight, 14 July, 2022.)

These areas are not just concerns but also opportunities for us to make a meaningful impact in shaping the future of the industry and the well-being of consumers.

Q

What is your company doing to deal with these challenges?

A

It is our responsibility to proactively stay ahead of the rapid changes in our industry, enabling our teams to anticipate, assess, and adapt to these developments. As the pace of change accelerates, we are focused on finding more efficient ways to monitor and evaluate these shifts. Our emphasis lies in enhancing our regulatory intelligence processes, leveraging advanced monitoring techniques and harnessing the capabilities of AI to improve efficiency. Additionally, we are dedicated to broadening the visibility of these changes across the organization, ensuring that insights from external forums and sector experts are effectively shared and integrated into our strategies.

In the realm of self-care products and advocating for their broader benefits, our efforts are centered on driving advocacy through our regulatory policy work at Bayer Consumer Health. Collaborating closely with self-care trade associations and industry partners, we are committed to amplifying the message of the socioeconomic impact and broader benefits of self-care products. This advocacy extends beyond regulatory authorities, involving collaboration with colleagues in public and government affairs to increase awareness and understanding among policy makers, politicians, and governments.

As regulatory professionals, we play a pivotal role in improving access to products and information, whether it involves advocating for the 'switch' of a medicine's status from prescription-only to OTC or championing the use of digital technologies such as electronic labeling to provide comprehensive, multi-language, audio, and visual product information to consumers. Our proactive engagement and advocacy efforts are aimed at driving positive change and expanding access to essential self-care solutions.

Bio

Jenny Holmes is an accomplished senior regulatory leader with over 15 years of experience in the consumer health sector. In her current role as global regulatory director she is responsible for regulatory policy and intelligence for Bayer's Consumer Health division.

Jenny holds a Master’s degree in Chemistry from Oxford University and has been an integral part of the regulatory affairs community since graduating in 2008. Throughout her career, she has had many accomplishments leading teams across key self-care therapeutic areas and diverse range of regulatory classifications. Her expertise encompasses a wide array of roles within global regulatory affairs teams, including Category Strategy Leadership for New Product Development pipelines for Global self-care brands. Passionate about developing high performing teams, Jenny supports the next generation of regulatory professionals through mentoring, whilst also championing graduate scheme programs alongside also fostering a culture of continuous learning and improvement within her team. Jenny continues to shape the future of consumer health through effective regulatory strategies that enhance consumers continued access and trust to self-care product and information.

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