Alvotech is seeking a proactive and detail-oriented Regulatory Affairs Manager for the Rest of World (RoW) region. In this position you will play a key role in ensuring global regulatory compliance, managing submissions, and collaborating with diverse teams and partners. Strong communication and problem-solving skills will help streamline processes and support our mission to deliver high-quality products worldwide.
Responsibilities:
- Maintain and update RoW dossier requirements in Veeva RIM.
- Develop best practices for document management.
- Notify partners and track RoW dossier updates.
- Lead regulatory interactions for LCM changes.
- Coordinate collection and completion of required documents.
- Facilitate material collection and legalizations from suppliers.
- Address submission requirements and escalate issues.
- Coordinate responses to RoW Health Authorities.
- Ensure timely receipt and archiving of dossiers.
- Design reports and analytics for RoW submissions.
- Support infrastructure building, process improvement, and project management.
- Communicate and collaborate across departments.
- Manage trackers and deliverables for RoW rollout.
- Implement and manage RoW regulatory activities in RIM.
Requirements:
- Minimum of Bachelor´s degree required
- Minimum of 5 years’ experience within the field of Regulatory Affairs
- Experience with Veeva required, Veeva RIMS and Veeva RIMS Connector is highly preferred
- Strong organizational and project management skills.
- Excellent communication and collaboration abilities.
- Detail-oriented with a focus on compliance and accuracy.
- Ability to adapt to changing regulations and requirements.
Benefits :
- An inspiring challenge to work with great co-workers on ambitious projects that change people’s lives.
- The chance to be part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration, and inclusion.
- Positive, flexible, and innovative work environment.
- A clear and developed organizational structure.
- Training and global opportunities to advance.
- A good work-life balance.
- Home internet and home office equipment.