Head of Regulatory Affairs* in Deutschland bei AiCuris GmbH & Co KG

AiCuris GmbH & Co. KG

Your mission

We are seeking a dynamic and experienced Head of Regulatory Affairs to lead NDA and MAA filings of our lead candidate Pritelivir. As Head of Regulatory Affairs, you will be responsible to drive and execute regulatory strategies for our therapeutic candidates, ensuring compliance with international regulatory requirements, and fostering a culture of regulatory excellence within the organization.

Responsibilities

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.

Your profile

Skills and qualification

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.

Why us?

What we offer

Unique corporate culture: Scientific excellence, a collaborative working environment and the passion to improve the lives of patients defines our work. With us, you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity, inspiration, as well as trustful collaboration.
Development: We encourage people to grow and strongly support individual development and learning opportunities.
Flexibility: Embracing flexible working accommodations, we enable our people to integrate business into their personal life.
Benefits: Employer-funded pension comes along with an attractive benefits package

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About us

AiCuris Anti-infective Cures AG is a leading clinical-stage pharmaceutical company developing novel, therapeutic candidates for the prevention and treatment of severe and potentially life-threatening infectious diseases in immunocompromised patients. Our front-runner drug Prevymis®, a prophylactic treatment for CMV infection in transplant patients, is marketed globally since 2017 by MSD (Merck & Co.). Prevymis® is followed by an innovative pipeline of antiviral agents including our wholly owned therapeutic candidate Pritelivir, which is currently in phase III pivotal clinical development.

Passionate about our mission to develop anti-infective therapeutics for patients in need, a team of internationally recognized experts is driving our research and development to improve the lives of patients. We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.

AiCuris is an employer that supports equal opportunities, diversity and inclusion. We welcome applications from people regardless of their national origin, skin color, religion, gender, age, marital status, disability, sexual orientation, gender identity or other legally protected characteristics.