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The specialist will provide subject matter expertise on chemical regulations, manage registrations, and oversee compliance reporting for the Lithuania site. They will also lead cross-functional projects, develop training programs, and maintain internal tools to ensure adherence to global chemical control frameworks.
The consultant will lead regulatory strategy for medical devices and combination products, managing interactions with health authorities and notified bodies. They will also oversee technical documentation, ensure compliance throughout the clinical development lifecycle, and collaborate with cross-functional teams on submissions.
The consultant will prepare CMC sections for regulatory submissions and manage lifecycle activities for biologics products. They will also provide technical consulting, coordinate project timelines, and develop regulatory strategies for combination products.
Develop and execute submission strategies for post-approval CMC activities, including variations and renewals for biologicals and vaccines. Coordinate with cross-functional departments to review study reports and ensure compliance with global regulatory requirements.
Own the full compliance mandate for the Lithuanian EMI license, serving as the primary liaison with the Bank of Lithuania. Establish the internal compliance framework and advise the CEO and Board on the regulatory implications of new products and market expansions.
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Ensure Hostinger's products and features comply with relevant laws and industry standards through proactive risk assessment and strategic guidance. Collaborate with cross-functional teams to draft commercial contracts and develop internal policies that support business growth.
Ensure Hostinger's products and features comply with laws and industry standards like DSA and DMCA. Collaborate with cross-functional teams to provide strategic legal guidance and manage commercial contracts.
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