Global Regulatory Specialist
5 days ago
In this critical position, you will play a key role in driving regulatory strategy and ensuring compliance with global and local regulations. You will collaborate closely with internal stakeholders, including Global Regulatory Affairs, Supply Chain, QA, Market Access, Marketing, and Medical.
The responsibilities of this role include leading regulatory projects, supporting interaction with Global Regulatory Affairs, communicating complex regulatory strategies with Health Authorities and internal stakeholders, and providing high-quality and timely regulatory input for planned filings and approvals.
You will have a strong understanding of regulatory compliance, excellent analytical and problem-solving skills, and the ability to work independently and as part of a team.
A bachelor's degree in a relevant field and more than 3 years of experience in the pharmaceutical industry or with Health Authorities are required. Fluency in Danish and excellent medical English are essential.
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Global Regulatory
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Copenhagen, Copenhagen, Denmark Genmab AS Full timeUnlock the Potential of Regulatory AffairsGenmab A/S is seeking a highly experienced and skilled Global Regulatory Expert to join its team. As a key member of the Global Regulatory Affairs organization, you will play a crucial role in shaping the company's regulatory strategies and ensuring the successful execution of global submissions.About the RoleThe...
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Copenhagen, Copenhagen, Denmark Kenvue Full timeKey ResponsibilitiesProvide regulatory input and technical guidance on local regulatory requirements to product development teams.Assess the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements.Prepare and submit regulatory submissions according to applicable...
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