Research & Development

About the role

The Regulatory Operations Associate is an important part of the team, helping to manage global regulatory activities after a product has launched. In this role, you’ll be responsible for preparing and delivering high-quality regulatory dossiers and technical files, making sure everything meets international standards and local requirements. You’ll work closely with different teams to ensure submissions are completed on time and maintain strong regulatory compliance throughout the entire product lifecycle

Your responsibilities

• Ensure that all regulatory activities are completed following best practices and in a consistent manner across projects.
• Support supply-related projects by providing regulatory guidance to ensure manufacturing sites can implement changes as planned. Proactively address unforeseen issues and deliver timely regulatory solutions to maintain compliance and project timelines.
• Collaborate effectively with cross-functional teams—including Safety, Quality, Medical, Marketing, Supply, Packaging, and R&D—to support project needs and manage stakeholder expectations.
• Work with local regulatory teams to identify key requirements and ensure submission needs are clearly defined and delivered on time.
• Deliver dossiers and technical files within agreed timelines, coordinating with partner functions to provide complete and accurate information for consistent project updates.
• Ensure high quality and accuracy of dossiers against agreed requirements, highlighting any potential issues and working with authoring functions and local regulatory authorities (LRA).
• Support efforts to refine regulatory processes and procedures to optimize efficiency.

The experience we're looking for

• Proven track record with at least 3 years in regulatory affairs, showcasing full proficiency in this role's requirements.
• Proficient in multitasking, executing tasks under pressure, and making objective decisions when faced with complex issues.
• Acute business acumen accompanied by commercial awareness.
• Demonstrated ability to cultivate insights from consumer interactions and translate them into strategic actions.
• Skilled in collaborating with teams across various functions, fostering an environment of partnership building.
• Agility to adapt to the ever-evolving technological landscape, complemented by a mindset that seeks to improve and advance current processes.
• Experience with product lifecycle management, intellectual property, and innovative workflows.

The skills for success

Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.

What we offer

Equality