Starte deine Karriere als Head of Regulatory Affairs* bei AiCuris GmbH & Co KG in Deutschland

• Drive the preparation, planning and implementation of the NDA/MAA filings for our lead product Pritelivir.
• Develop comprehensive regulatory strategies for the development and registration of additional pipeline candidates, collaborating closely with cross-functional development project teams.
• Provide regulatory guidance and direction to project teams driving regulatory compliance throughout the product lifecycle.
• Drive interactions with international regulatory authorities, including the EU and FDA for all pipeline candidates.
• Supervise and coordinate setup of regulatory dossiers for global product registrations, including electronic submission formats.
• Monitor the regulatory landscape and evolve the regulatory affairs department.
• Refine processes, procedures, and infrastructure to enhance the efficiency and effectiveness of regulatory activities.
• Manage and mentor the regulatory affairs team, providing training, guidance, and opportunities for professional development.

• PhD in Medicine, Pharmacy, Chemistry, Biology, Biochemistry, or equivalent education followed by at least 10 years working experience in Regulatory Affairs.
• Experience in developing regulatory strategy and proven ability to interact with FDA and EMA
• Proven ability to serve as a team leader, including the ability to motivate, mentor, and develop team members.
• Understanding of clinical development throughout all development phases including market approval and post-approval commitments.
• Excellent interpersonal with the ability to effectively collaborate with cross-functional teams.
• Strong communication and stakeholder management as well as scientific/regulatory writing skills in English.
• Ability to adjust to changing environment with team oriented problem-solving mindset.

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