About This Role
Supporting the execution of regulatory activities for assigned products is the core of this specialist role, ensuring compliance with local regulations and company policies. The position involves contributing to regulatory applications, managing complex matters with senior colleagues, and helping to minimize supply interruptions.
Responsibilities
- Support the execution of regulatory activities for products within the assigned portfolio, in compliance with local regulations, approved plans, and company policies
- Contribute to the timely preparation, submission, follow-up, and maintenance of regulatory applications, including product registrations and lifecycle management activities
- Support the management of complex or high-impact regulatory matters in collaboration with senior Regulatory Affairs colleagues, progressively increasing technical knowledge, accountability, and independence
- Support regulatory compliance and business continuity, helping to minimize supply interruptions and risks that could affect patients or product availability
- Prepare and support submissions for new marketing authorizations, variations, renewals, notifications, and other lifecycle management activities for the assigned portfolio
- Maintain product licenses and regulatory documentation in accordance with local requirements, approved product information, supply needs, and internal procedures
- Perform assigned activities in alignment with applicable standard operating procedures and regulatory requirements
- Support routine interactions and follow-up with local regulatory authorities
- Escalate complex questions or issues to senior team members or the Regulatory Affairs Manager
- Assist in preparing accurate and timely responses to health authority questions and requests
- Support completion and tracking of post-approval commitments within required timelines
- Contribute to the preparation of regulatory documentation and provide operational support for new product applications and launches
- Review promotional and non-promotional materials for regulatory compliance, following regulations and established review processes and guidance
- Support labeling, prescribing information, and packaging component implementation to maintain alignment with approved information and local regulations
- Maintain regulatory databases, trackers, records, and submission documentation accurately and on time
- Provide regulatory support to cross-functional activities involving Medical, Commercial, Market Access, Quality, Supply Chain, and other relevant functions
- Monitor regulatory updates, communicate relevant changes to the team, and support assessment of their potential impact
- Organize priorities, identify risks or delays, and provide timely status updates to the manager and relevant stakeholders
