Submission Compliance Specialist

1 day ago


Stockholm, Stockholm, Sweden Karo Group Full time
Our Culture
At Karo Healthcare, we strive to create a collaborative, innovative, and dynamic environment where talented individuals can thrive. We believe in fostering open-mindedness, encouraging individual initiatives, and promoting cross-functional collaboration. As a result, we offer a stimulating atmosphere for professionals seeking challenging roles, continuous learning, and career progression.

Key Responsibilities
As a Team Lead for Pharmaceutical Submissions & Compliance, Global Regulatory Affairs, you will be responsible for: Securing a dedicated and motivated team to drive maintenance and development of Karo medicinal products. Overseeing the management of Submissions & Compliance activities, including strategies, submission planning, and performance. Ensuring compliance with artwork processes, eRIMS data system, and archiving. Coordinating and supporting local RA consultants to ensure compliance with local requirements and implement SPOR from a regulatory affairs perspective. Working closely with cross-functional teams to provide regulatory input and support product launches. Managing and maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents. Providing regulatory input to cross-functional teams/projects.

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