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Global Regulatory Affairs Manager
Karo HealthcareSwedenfull_timeVerifiedPosted 25 Apr 2025
About the role
<p>Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as <em>E45, Pevaryl, Lamisil, Nutravita, Decubal</em> and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.<br/></p><p>Join us at Karo Healthcare on our exciting journey. We're currently looking for a <strong>Global Regulatory Affairs Manager </strong>for our headquarter in <strong>Stockholm, Sweden.</strong></p><p></p><h3><strong>What’s in it for you?</strong></h3><p>A unique chance to join a fast-growing, international company where you’ll own critical submissions across a global portfolio. You’ll work independently, yet cross-functionally - engaging with diverse markets, including the Middle East, Africa, and Asia. If you’re ready to bring structure, strategy, and energy to a hands-on regulatory role, this is your opportunity to grow.</p><p></p><h3><strong>What you’ll be doing</strong></h3><p>In this role, you’ll lead global regulatory submissions for our medicinal products and serve as a strategic partner across functions. You’ll work independently, adapt quickly, and contribute with a strong understanding of how regulatory work drives broader business outcomes.</p><ul> <li> Lead and manage regulatory submissions for medicinal products across assigned global regions </li> <li> Coordinate and prepare regulatory documentation (excluding core dossier creation) </li> <li> Ensure compliant, up-to-date product artworks and labelling, including serialization requirements</li> <li> Manage artwork updates and ensure local compliance </li> <li> Collaborate cross-functionally to provide strategic regulatory input </li> <li> Support geo expansion, launch in new markets for currently registered products </li> <li> Coordinate with subsidiaries, partners, consultants, and publishing vendors </li> <li> Oversee translations and ensure up to date local product databases and websites</li> <li> Maintain and update internal RIM system and IDMP/SPOR </li> <li> Contribute to the development and upkeep of internal SOPs </li> <li> Stay up to date with evolving global regulatory standards and frameworks </li> </ul><p><strong>Requirements</strong></p><ul><li>University degree in Life Sciences </li></ul><ul> <li>5+ years of experience in Regulatory Affairs, with a clear focus on medicinal products</li> <li>Strong track record in EU regulatory procedures (NP, DCP, MRP) and variation management </li> <li>Global experience (especially Middle East, Africa, Asia) is a strong plus </li> <li>Fluent in English; French, Spanish or Arabic is a plus </li> <li>Familiar with artwork processes and label compliance </li> <li>Hands-on experience with regulatory systems (e.g. RIM, IDMP/SPOR) </li> <li>Strong communicator, structured, and comfortable working independently </li> <li>Adaptable, proactive, and excited by cross-functional collaboration in a dynamic environment</li> </ul><p></p><p>Ready to make your mark in a growing global company? Apply now and be part of the next chapter at Karo Healthcare.</p><p><strong>Benefits</strong></p><ul> <li>Opportunity to create, grow, and encourage</li> <li>Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions</li> <li>Flexible schedule, hybrid model with the primary work place in the office, and life-work balance</li> <li>Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry</li> <li>Very positive work environment in a dynamic, international, and motivated team</li> <li>Start-up spirit while being a part of the large international organization with strong values</li> </ul><p> </p><p>Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age. </p>
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