Job Description

Operational Regulatory Affairs Specialist

ABOUT THE ROLE

As a Regulatory Affairs Specialist, Operation you will be a key member of the Regulatory Affairs Operations team, enabling the execution of regulatory activities that are efficient, timely, and compliant.

This role sits within the Regulatory Affairs Operations team , where precision, structure, and follow-through are critical. You will coordinate and track complex regulatory activities, support submission and labeling processes, and ensure that regulatory data and documentation are

accurate, complete, and aligned across systems.

Success in this role means effectively coordinating and tracking regulatory operational activities to ensure submissions, labeling, and document workflows are executed accurately, on time, and in compliance. You will maintain tracking tools, monitor progress across multiple projects, and proactively follow up on deliverables.

You will work closely with Regulatory Affairs, Quality, Clinical, Operations, and R&D, and support the timely execution and continuous improvement of processes, tools, and ways of working.

WHAT YOU WILL DO

• Support regulatory project tracking and coordination to ensure timely execution of tasks and deliverables.
• Maintain and continuously update tracking tools to monitor timelines, milestones, and task status.
• Monitor progress of regulatory activities and proactively follow up with stakeholders to ensure timely completion.
• Support alignment and coordination across cross-functional teams including Regulatory Affairs, Quality, Clinical, Operations, and R&D.
• Ensure tracking data is accurate, complete, and consistently up to date.
• Compile, consolidate, and track applicable external regulatory requirements, including regulations, standards, and guidance documents.
• Support communication of relevant requirements to cross-functional stakeholders.
• Assist in tracking compliance gaps and implementation plans.
• Coordinate document routing, review cycles, and collection of required approvals and signatures in accordance with established procedures.
• Coordinate and track labeling activities/
• Including label creation requests, artwork review cycles, and approval workflows.
• Support the accuracy, completeness, and compliance of labeling deliverables in collaboration with relevant stakeholders.
• Support the maintenance and updating of SOPs, templates, work instructions, and process documentation to ensure consistency and transparency.
• Participate in continuous improvement initiatives related to regulatory operations, submission processes, templates, trackers, and automation tools.
• Work within the Regulatory Information Management (RIM) system.
• To enter, update, and track regulatory records and submission-related data.
• Support preparation of regulatory submissions from an operational perspective, including document collection, organization, completeness checks, and publishing.
  
  

WHAT YOU WILL BRING

• Bachelor’s degree in Life Sciences, Business Administration, or a related field.
• At least 2 years of hands-on experience in roles involving task tracking, coordination, follow-up, and working within controlled processes or procedures (such as Regulatory Affairs, Quality, Validation, or Operations).
• Strong organizational, interpersonal, and communication skills.
• High attention to detail with the ability to manage multiple tasks and priorities effectively.
• Proficiency in Microsoft Excel, including formulas, pivot tables, and conditional formatting.
• Experience working with tracking tools and project coordination platforms.
• Familiarity with project management tools such as Smartsheet or Monday.com – an advantage.
• Experience with document control systems, RIM systems, or ERP tools – an advantage.
• Strong English proficiency, both written and verbal.

WHO YOU ARE

• Proactive and reliable, with a strong sense of ownership and accountability.
• Highly organized and detail-oriented, with the ability to bring structure to complex workflows.
• Comfortable working across multiple stakeholders and functions, with strong follow-up and coordination skills.
• Adaptable and able to manage changing priorities in a dynamic environment.

ABOUT NOVOCURE

Novocure is a company with a powerful mission, to extend the lives of people living with some of the most aggressive forms of cancer.
Here your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference.
We’re a company with the drive of a startup and the strength that comes with 25 years of success.

Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies.
This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers.

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy