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Global registration* projects are complex undertakings that demand not only regulatory expertise but also excellent planning, organisation and teamwork. Without careful management, these projects can become challenging to navigate and may quickly spiral into inefficiency. In a dynamic environment such as global regulations, defining clear roles, establishing robust processes, and maintaining effective communication among project participants is essential. Professional project management plays a pivotal role in ensuring streamlined execution and achieving optimal results. Are you curious to learn more about the synergy between these two roles? Then read on to learn about the ISS AG experts Nina Nowka, Head of Regulatory Affairs, and Uriel Zemp, Senior Project Manager.

The Strategic Value of Role Division and Planning

A key advantage in managing global registration projects is distinguishing between the roles of the project manager (PJM) and the subject matter expert (SME). This division ensures a structured allocation of responsibilities, enabling the project to progress smoothly and efficiently. The PJM oversees overall planning, escalation management, and communication, while the SME focuses on execution and providing specialised expertise. Before diving into the best practices and tools shared by Nina and Uriel, it is worthwhile to take a step back and reflect on how these roles complement and support one another.

PJM – Coordination and alignment

The PJM plays a central role in "holding the threads together", ensuring that all internal and external stakeholders are aligned and that the project is delivered on time and within budget. Collaboration between PJM and SME is particularly crucial at the start of a project. The PJM must understand what is required and which priorities need to be established to create a clear roadmap for success, relying on the SME's expertise to ensure all aspects of the project are accurately addressed. The PJM often achieves this by asking insightful questions and maintaining a clear focus on the overall project objectives.

SME - Expertise and implementation

The SME is responsible for the technical implementation of a project, bringing the necessary expertise and experience. In turn, the SME provides valuable technical insights and clarity that support the PJM in making informed decisions, especially when defining priorities and strategies. The PJM and SME work together to combine their unique strengths: the PJM broadens the perspective, ensuring potential risks and challenges are identified early. At the same time, the SME provides in-depth technical expertise to address them effectively.

As with any project, teamwork is also crucial for international registration projects. A well-coordinated partnership between the SME and PJM not only ensures project quality but also reduces the risk of errors or delays. In the registration process, where extensive technical knowledge and experience are indispensable, the collective knowledge of the team becomes a critical success factor. Clear and precise communication plays a pivotal role in this dynamic. Regular updates and active efforts to seek clarification from both parties help prevent misunderstandings. The PJM's role as a "sparring partner" exemplifies this collaboration. The PJM ensures a clear understanding of the requirements and perspectives of all relevant stakeholders, facilitating their integration into the project. A strong team can effectively navigate challenges and maintain high motivation, even during demanding phases of a project.

There is a risk of getting lost in the details when handling complex regulatory requirements and losing sight of the bigger picture, even though the main points can often be summarised in just two sentences.

Nina, in your opinion, what makes project management valuable for global registrations?

In my view, global registrations consist of numerous smaller projects within a larger overarching project, sometimes making it challenging for them to fit neatly into the traditional “project” definition. While individual submissions typically have a clear start and end, the broader activity of maintaining market access is ongoing. Without proper organisation, this complexity can quickly become overwhelming. From our experience, a clear division of roles between the PJM and SME is crucial for ensuring efficient day-to-day operations. The PJM plays a central role in "keeping everything connected” and guiding the SME in overall prioritisation in this dynamic environment. Additionally, the PJM can handle reporting tasks and support when escalation is required.

 


Collaboration That Delivers

Flexibility emerges as a cornerstone of effective project planning in day-to-day operations. Global registration projects are often subject to unforeseen circumstances, whether from regulatory changes or evolving customer requirements. In such instances, the PJM must respond swiftly, explore alternative solutions, and clearly understand the broader implications of any adjustment. Anticipating and communicating potential risks at an early stage is a critical part of this role. Equally important is fostering mutual understanding and empathy among all project participants. Beyond technical requirements, successful collaboration often hinges on sensitivity to the perspectives and needs of others. This is particularly true in the collaboration between PJM and SME, where interpersonal dynamics can be as impactful as technical knowledge. When both parties actively adopt each other’s perspectives, it not only enhances problem-solving but also ensures a smoother, more cohesive project workflow.

Projects such as global registrations can differ significantly in complexity. While smaller projects are relatively straightforward, larger projects present greater challenges. This is particularly true for global registration projects, involving multiple departments and stakeholders, and unforeseen authority requests may arise. Close cooperation between PJM and SME is essential to ensure that changes to the schedule or budget are effectively communicated and implemented promptly. Experienced PJMs can provide valuable support by using appropriate tools and with their ability to align all stakeholders.

Project management is fundamentally a mindset. While tools provide valuable support, true success comes from staying focused, adaptable, and consistently aligned with the project’s goals and vision.

Uriel, which tools would you recommend for global registration projects?

To manage the complexity of global registration projects, there are various tools and methods available. Specific tools I see are:

– Project charter: Particularly valuable at the beginning of a project, this document helps define the most important parameters and ensures everyone involved is on the same page. The selection of the right tools depends heavily on the size and complexity of the project. For smaller projects, simple Excel spreadsheets or budget-controlling tools are usually sufficient, while larger projects can benefit from more complex project management tools.

– RAID log: Another helpful tool for documenting risks, assumptions, issues and dependencies. The RAID is used to document and track key elements that impact the project.

– Risk register / Risk log: These tools are designed to systematically identify and monitor potential risks that may affect the execution of a project. Once risks are identified, they can be monitored and/or mitigated. These tools are mostly used during execution and can be integrated into the project plan. Often, this is done as part of the RAID log but, it can also be an effective tool if no complete RAID log is maintained.

– Project plan: This is one of the most important documents for efficient execution. The project plan outlines task responsibilities, dependencies and deadlines, providing clarity and transparency within the team. Oftentimes this is done in Excel.

– KANBAN: Although not useful in every project, KANBAN can be useful in larger, more agile projects to visually organise tasks and clearly define priorities.

 


 

Navigating Buzzwords: Team, Workload, and Questions

Collaboration and specialised fields often come with buzzwords that can evoke both positive and mixed reactions. Nina and Uriel both have a different views on the terms team, workload and question.

Team

Team

A strong team is crucial, as it's nearly half the battle, and collaboration is essential because you can't succeed alone. In global registrations, shared knowledge and motivated teamwork make a significant difference, even when tasks like registrations feel tedious or monotonous.

Team

Team

Collaboration is crucial because you can't handle everything on your own, whether it's time or expertise, and shared success or overcoming crises together is rewarding. A strong team leads to great results and high quality.

Workload

For me, the workload is highly variable; sometimes, it is intense, and other times, it is lighter. The high art is managing tasks efficiently so you're consistently busy, avoiding lengthy delays or getting stuck in a hole.

Workload

I have a constant workload, with tasks always emerging, and the key is managing them thoughtfully. While it may seem negative, it is, in fact, a positive and engaging challenge for me.

Question

Asking the right question at the right moment can significantly boost efficiency and be valuable. There are no foolish questions, and all inquiries should be welcomed.

Question

Questions are always interesting for me. Finding the path to clarity in times of ambiguity is very exciting.

Team

Nina

A strong team is crucial, as it's nearly half the battle, and collaboration is essential because you can't succeed alone. In global registrations, shared knowledge and motivated teamwork make a significant difference, even when tasks like registrations feel tedious or monotonous.

Uriel

Collaboration is crucial because you can't handle everything on your own, whether it's time or expertise, and shared success or overcoming crises together is rewarding. A strong team leads to great results and high quality.



Workload

Nina

For me, the workload is highly variable; sometimes, it is intense, and other times, it is lighter. The high art is managing tasks efficiently so you're consistently busy, avoiding lengthy delays or getting stuck in a hole.

Uriel

I have a constant workload, with tasks always emerging, and the key is managing them thoughtfully. While it may seem negative, it is, in fact, a positive and engaging challenge for me.



Question

Nina

Asking the right question at the right moment can significantly boost efficiency and be valuable. There are no foolish questions, and all inquiries should be welcomed.

Uriel

Questions are always interesting for me. Finding the path to clarity in times of ambiguity is very exciting.

 


The Additional Superpowered Teammates That Would Boost the Two Experts

The collaboration between project management and global registration experts already generates impressive results, almost akin to superpowers. However, both experts see value in recruiting fictional superheroes to enhance their daily work further. Nina would select Vision from the Marvel Cinematic Universe. As an android powered by artificial intelligence, Vision possesses exceptional computational and analytical skills, enabling him to process vast amounts of information and solve complex problems with remarkable speed. His ability to speak any language and travel quickly and emission-free enhances his capacity to address inquiries from authorities or local partners on-site. Vision exemplifies seamless communication and effective problem-solving in any scenario. Uriel would choose Marvel’s Mantis, who embodies the importance of interpersonal dynamics. Mantis’s empathetic abilities allow her to deeply understand others’ needs, intentions, and perceptions. By having a deep understanding of what everyone wants, you can guide the situation in a way that maximises buy-in, ensures alignment from all parties and creates the best possible outcome for all parties.

Global registrations and similar projects rely on effective planning, communication, specialised knowledge, and strong interpersonal cooperation. Success depends not only on the right tools but also on understanding the needs and challenges of all stakeholders. The collaboration between PJM and SME is crucial - they work together to overcome challenges and drive the project’s success. At ISS AG, the art of project management goes beyond tools and methods, leveraging strengths such as flexibility in adapting to changes, effective communication, and team support. This approach is especially valuable for global registrations, where the international context brings constant new challenges. The ISS AG integrated approach comes to life daily as PJM and SMEs collaborate to achieve exceptional outcomes.   



While the term "registration" may appear to simplify the complexity of market approval processes, it is a recognised and practical term widely used to facilitate clear international communication. We are mindful that it encompasses not only administrative tasks but also rigorous evaluations, certifications, and compliance efforts. In our daily work, we ensure the use of official terminologies specific to each jurisdiction (back to top)
 


About The Experts


Uriel brings eight years of experience as a project manager and consultant to his role at ISS AG, which he joined in 2024. He holds a BSc in Biochemistry, a BA in Business Administration and an MSc in Agricultural Sciences. Additionally, he is a certified Scrum Master.
Uriel Zemp
Senior Project Manager
Nina is an expert in international registrations bringing over five years of experience to the field. Following a successful Taekwondo career, she studied Biochemistry and obtained her BSc in 2019. After that, she joined ISS AG and did her master’s degree in parallel, receiving the MSc in Molecular Life Sciences (in Biochemistry) in 2021.
Nina Nowka
Head of Regulatory Affairs

 


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