
Pharma Submissions Specialist
2 days ago
Karo Healthcare is a dynamic and growing company that prioritizes making smart choices for everyday healthcare. With a diverse portfolio across multiple categories, we aim to empower people to make intelligent health decisions.
We are currently seeking a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs for our headquarter office in Stockholm, Sweden.
The successful candidate will be responsible for securing a dedicated team to drive maintenance and development of Karo medicinal products. This includes managing Submissions & Compliance activities, ensuring compliance with artwork processes, eRIMS data systems, and archiving.
The role requires overseeing SPOR implementation in Karo's data systems from a regulatory perspective. The candidate will also coordinate and support local RA consultants to ensure compliance with local requirements.
This is an exciting opportunity for someone who wants to contribute to a dynamic, international, and motivated team while working on challenging projects with a direct impact on our customers and the industry.
- Personnel responsibility and competence development for the Submissions & Compliance group
- Resource allocation
- Accountable for the management of Submissions & Compliance activities including strategies, submission planning and performance
- Ensuring compliance with and oversight for the artwork process as well as with Karo relevant eRIMS data system and archiving
In addition to these responsibilities, the ideal candidate will have extensive experience in Global Regulatory Affairs and be able to maintain current knowledge of existing and emerging regulations, standards, or guidance documents.
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