Viatris’ Suzanne Keating discusses the changing face of pharma frameworks in Ireland and offers advice for young professionals.
“After finishing my university degree in chemistry in the 1990s, employment opportunities in Ireland were few and far between,” explained Suzanne Keating, a regulatory affairs senior director at Viatris.
“I embarked on a graduate development programme at what was then the Welcome Foundation, now part of GlaxoSmithKline, in the UK. My first role was in a product development laboratory as an analytical chemist conducting stability testing to support product shelf life for a wide range of formulation types.”
Soon after, Keating began applying for regulatory affairs roles. After spending some time at various companies – including a veterinary pharmaceutical company and Abbott – she took on a role at Bioniche Pharma. This company was eventually acquired by Mylan, which then combined with Upjohn to become Viatris in November 2020.
“I have been with the company for many years and am fulfilled by the continuous opportunities to learn, develop my skills and get experience with different types of products and global regulations whilst at the same time progressing my career.”
What is the current landscape in Ireland like?
Given the large number of pharmaceutical and medical technology companies in Ireland, there continue to be many diverse career paths in regulatory affairs. From small start-up companies where you may be part of a very small regulatory team to multinational companies like Viatris with a large regulatory department, the opportunities in Ireland are endless.
Investment in research and development in Ireland means there are plenty of opportunities to get involved in new product submissions and support the launch of these products. With Ireland being a hub for pharmaceutical manufacturing, this creates significant demand for life cycle management and regulatory compliance activities to support commercial operations.
What opportunities exist for graduates and professionals in regulatory affairs?
Entry-level graduate roles typically involve preparing documentation and contributing to a regulatory submission under the guidance of a more senior member of the team. As experience builds, there are greater opportunities to lead projects and get involved in the review of regulatory submissions, as well as manage a team if people management is of interest.
There are many possibilities in regulatory affairs, for example preparing and reviewing labelling and ensuring it is kept up to date, reviewing promotional materials to ensure they meet regulatory requirements and preparation of the scientific, clinical or non-clinical content of product applications. Many roles operate on a global scale, providing valuable insight into regulations worldwide.
What kind of applicant is most attractive to an organisation like Viatris?
Viatris is a global company with a vast array of products in its portfolio. Dynamic individuals who have demonstrated their ability to work across different areas of regulatory affairs and have experience with different product types shows adaptability. Applicants with experience of working across different cultures show they will understand how to collaborate in multicultural teams, which is part of everyday life at Viatris. A ‘can do’ attitude and a curious nature are also important.
All new colleagues take part in our induction programme and within regulatory affairs we have our own global regulatory affairs learning and development team who ensure new team members get the necessary training and support to allow them to be successful in their role.
How might a potential applicant stand out in the crowd?
I view a CV as an opportunity for candidates to present their experience clearly and highlight what is most relevant to the role. I want to be able to determine if the applicant has written and/or reviewed regulatory submissions, what life cycle phase the candidate has experience of, the types of products they have worked on and the regulatory frameworks they have worked within. At the interview stage, I am always impressed by applicants who have done their research and know about Viatris, are clear on the role they have applied for and come prepared with thoughtful questions.
A candidate who can communicate how they have navigated complex situations or challenges with real-life examples will stand out. For applicants without prior industry experience, there is a wealth of information easily accessible online about the company as well as regulations applicable to the products Viatris manufactures.
It’s perfectly acceptable to be upfront about not having any practical experience of using the regulations, but candidates who can demonstrate where to find relevant information and explain how they anticipate regulations are applied show strong initiative and potential.
What are the challenges associated with recruitment in this space and how are they overcome?
Often there are a large number of applicants and shortlisting candidates can be challenging. Due to the diverse array of medical products available and the associated regulatory roles, it is not always easy to determine from an application alone whether a candidate has the required experience.
In these situations, the Viatris talent management team can follow up with a quick screening call to find out specifics before a formal interview. Another way to overcome recruitment challenges is to recruit internally; several members of the team have successfully transitioned from laboratory or QA backgrounds, supporting both capability building and internal career development.
How can leaders create productive and cohesive working environments?
Communication is paramount and it is important for leaders to encourage positive interdepartmental relationship building as regulatory affairs offers the opportunity to work cross-functionally within the organisation. Development of a new product culminates in the regulatory submission and to get to this point requires a cross-functional team effort. Being approachable and encouraging openness within regulatory and cross-functional teams is important so that colleagues are comfortable raising potential risks associated with achieving regulatory goals for discussion.
When challenges arise, it is critical to listen and remain positive and solution focused to maintain cohesiveness within the team and keep project goals on track. Being able to clearly communicate the contribution required from the regulatory team to achieve business goals, understanding team members’ career aspirations and aligning these with business goals, all helps to promote productivity.
Have you any predictions for how the regulatory affairs space might evolve over the course of 2026?
I feel the positive business impact of robust regulatory strategies will be increasingly recognised and will result in a greater focus on the strategic importance of the regulatory affairs function. Post Covid there has been a greater focus on supply continuity and regulatory roles will continue to evolve in response to legislation mandating companies to monitor and report shortages.
Artificial intelligence remains a key topic of discussion, so it will be interesting to see how this will impact regulatory affairs; I don’t foresee a significant impact in 2026 but expect to see more information on opportunities for furthering the use of AI in this space.
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