regulatory affairs specialist.

• Collaborate with teams to ensure efficient and seamless Regulatory Information Management across all stages.
• Oversee the regulatory data for assigned areas, ensuring alignment with industry standards, regulatory requirements, and business processes.
• Prepare and submit regulatory data submissions (XEVMPD, IDMP, etc.) to health authorities.
• Continuously develop expertise in areas vital to successful RIM execution, with a focus on technical skills and international regulations.
• Engage with partners, affiliates, and stakeholders to manage regulatory data and ensure adherence to standards and procedures.
• Monitor legislative changes impacting regulatory information, reviewing and assessing regulations, guidelines, and technical specifications.
• Act as a subject matter expert in the analysis, management, and quality control of regulatory data standards.

If you're excited about this type of position in the future! Submit your application and apply now!

Required:

• University degree in life sciences or equivalent experience in the pharmaceutical/medical industry.
• Strong understanding of the pharmaceutical drug development process.
• Excellent analytical and critical thinking abilities.

Preferred:

• Strong problem-solving and conflict resolution skills.
• Ability to prioritize, set performance targets, and manage projects effectively.
• Ability to innovate and implement best practices through business process analysis and design.

Collaboration and continuous learning are core to how we operate and succeed. In Regulatory, we work together across global teams, therapeutic areas, and the external community to share insights and expertise. We are proactive, self-driven individuals who take ownership of our growth, both personally and professionally.

We are a compassionate, results-driven team, always ready to take initiative. If this resonates with you, we invite you 

to apply for the Reg role.

• Masters or equivalent