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Regulatory Affairs Leader
2 days ago
Karo Healthcare is a dynamic and growing company focused on making smart choices for everyday healthcare. We own and sell over 80 brands in about 90 countries.
Job OverviewWe're looking for a highly skilled Regulatory Affairs Leader to join our headquarters in Stockholm, Sweden. This individual will be responsible for leading the Submissions & Compliance team and ensuring compliance with relevant regulations.
Main Responsibilities- Leadership and Team Management:
- Personnel responsibility and competence development for the Submissions & Compliance group
- Securing a dedicated and motivated team to drive maintenance and development of Karo medicinal products
- Resource allocation
- Regulatory Compliance and Strategy:
- Accountable for the management of Submissions & Compliance activities including strategies, submission planning and performance
- Ensuring compliance with relevant regulations, including artwork process and eRIMS data system
- Oversight of SPOR implementation in Karo's data systems from RA perspective
- Cross-Functional Collaboration:
- Coordinating and supporting local RA consultants to ensure compliance with local requirements
- Contact person for eCTD Publishing
- Supporting Head of Global Regulatory Affairs with budgeting and follow up
- Regulatory Documentation and Knowledge:
- Creating and/or review of regulatory documentation as relevant for submissions
- Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents
The ideal candidate should have a strong background in Global Regulatory Affairs and at least 5 years of experience in a similar role. They should also possess formal or informal leadership qualities and a good understanding of regulatory requirements and applicable legal frameworks.
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