Challenge and opportunity in Ireland’s regulatory pharma space

Suzanne Keating, a senior regulatory affairs director at Viatris, reflects on the evolving landscape of pharmaceutical regulations in Ireland and offers guidance for aspiring professionals in the field. Keating, who initially pursued a chemistry degree in the 1990s, found limited job opportunities in Ireland at that time. She subsequently joined a graduate development program at the Welcome Foundation, which later merged into GlaxoSmithKline, where she worked in product development as an analytical chemist conducting stability testing.

Her career progression led her to various companies, including a veterinary pharmaceutical firm and Abbott, before she joined Bioniche Pharma, a company later acquired by Mylan and subsequently incorporated into Viatris in 2020. Keating emphasizes the continuous learning opportunities at Viatris, where she has had the chance to work on diverse products and navigate various global regulations.

She appreciates the evolving nature of her role and the chance to gain experience across different product types and regulatory frameworks.

Ireland boasts a thriving pharmaceutical sector with numerous companies, offering a wide range of career paths in regulatory affairs, from small start-ups with limited teams to multinational corporations like Viatris with extensive regulatory departments. The country's investment in research and development, coupled with its position as a pharmaceutical manufacturing hub, creates substantial demand for life cycle management and regulatory compliance activities to support commercial operations.

Entry-level roles often involve drafting documentation and contributing to regulatory submissions under the guidance of senior colleagues. As professionals gain experience, they can assume leadership roles, manage teams, and oversee the review of regulatory submissions. Key responsibilities may include preparing and reviewing labeling, ensuring promotional materials comply with regulations, and compiling scientific, clinical, or non-clinical content for product applications.

These roles frequently operate on a global scale, providing valuable insight into international regulations. Viatris, a global company with a broad product portfolio, values dynamic professionals who can adapt to various regulatory environments and collaborate effectively across cultures. A "can-do" attitude and an inquisitive nature are highly regarded, as they demonstrate a strong work ethic and a willingness to learn.

Viatris places considerable emphasis on comprehensive onboarding, with new hires participating in a global regulatory affairs induction program and receiving support from the company's global regulatory affairs learning and development team. When reviewing resumes, Keating focuses on candidates' experiences with regulatory submissions, their involvement in specific life cycle phases, the types of products they have worked on, and their familiarity with regulatory frameworks.

During interviews, Keating is impressed by candidates who have researched the company, understand the role they are applying for, and come prepared with insightful questions. Demonstrating the ability to navigate complex challenges and providing real-life examples of problem-solving skills can set applicants apart. For those without prior industry experience, extensive online resources are available to learn about Viatris and the applicable regulations for the company's products.

It's acceptable to acknowledge a lack of hands-on experience, but candidates who can showcase their research skills and anticipate regulatory application demonstrate initiative and potential.

Due to the diverse range of medical products and associated regulatory roles, shortlisting candidates can be challenging. In such cases, Viatris may conduct a preliminary screening call to gather more information before proceeding to a formal interview. Recruiting internally is another strategy to overcome recruitment hurdles, as team members have successfully transitioned from laboratory or quality assurance backgrounds, bolstering the team's capabilities and facilitating internal career growth.