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Regulatory Affairs Expert
2 weeks ago
We are seeking a dedicated and experienced Regulatory Affairs Manager to join our team at Oresund Pharma ApS.
Job Description:The successful candidate will be responsible for developing and maintaining a global product portfolio following regulatory requirements and commercial demands. Key responsibilities include lifecycle management, ensuring products comply with regulations, preparing and reviewing regulatory submissions, and maintaining product information.
Additional responsibilities include monitoring timelines, keeping up-to-date with national and international legislation, guidelines, and establishing relationships with local competent regulatory health authorities.
A strong scientific background and minimum of 4 years of experience in regulatory activities is required. Proficiency in MS 365 and Danish or Nordic native language skills are also necessary.
We offer an opportunity in a company with an entrepreneurial and inclusive work environment, focusing on both maintaining and growing the core business and diversifying our product portfolio into new categories and regulatory regimes.
