Regulatory Affairs Director
2 days ago
Karo Healthcare, a dynamic and rapidly growing company, is at the forefront of making informed health decisions for everyday healthcare. With an extensive portfolio across multiple categories, including medical products, we own and sell over 80 brands in approximately 90 countries. Our core mission is to empower individuals with smart choices for better health outcomes.
We are currently seeking a Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs to join our headquarter office in Stockholm, Sweden.
Key Responsibilities- Lead the Submissions & Compliance group and oversee their development, ensuring a dedicated team drives maintenance and enhancement of Karo medicinal products
- Manage resource allocation and be accountable for strategies, submission planning, and performance related to Submissions & Compliance activities
- Ensure compliance with artwork processes and eRIMS data system, as well as archiving requirements
- Oversight of SPOR implementation in Karo's data systems from a Regulatory Affairs perspective
- Coordinate local RA consultants to ensure compliance with local requirements such as databases and compendial documents in line with Karo processes
- Contact person for eCTD publishing and support Head of Global Regulatory Affairs with budgeting and follow-up
- Develop and maintain Submissions & Compliance SOPs and associated instructions
- Adequately plan, prepare, submit, and follow up on regulatory procedures and tasks for assigned portfolios while considering cross-functional impact and communication needs
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Director Medical Affairs
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