Your mission
As US Director Regulatory Affairs*, you will develop and execute regulatory strategies to advance our anti-infective portfolio through all stages of development (early to late phase). As a member of the regulatory affairs team your key responsibilities will be to support/co-lead the NDA for our most advanced asset in close collaboration with the cross functional Pritelivir project team. The US Director Regulatory Affairs* will provide expertise in translating regulatory requirements into practical plans and will facilitate/lead authority meetings with respect to document preparation and meeting discussions as well guiding the cross functional project team. The position, based in the US (remote), will require working with a team located mainly in Europe and will therefore require both flexibility and ability to work in an international environment. The US Director*, will report to the Vice President Regulatory Affairs and will be a core member of a small but agile regulatory team.
Responsibilities:
- Support/co-lead new drug application (NDA) in the US (dossier preparation, interaction with FDA, responses to question) to ensure regulatory approval
- Once product is approved for marketing, provide the necessary support to ensure compliance with local regulatory requirements
- Act as the contact point for FDA across the AiCuris portfolio
- Contribute to the development of clinical regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations
- Plan, coordinate and supervise all types of submissions to FDA for assigned products/projects
- Provide strategic/hands on support for the various compounds of the portfolio as well as potential line extensions
- Provide regulatory assessment during due diligences
- Maintain up-to-date knowledge of highly complex regulatory requirements and communicates changes to project teams
- Contribute to internal regulatory policies and procedures to achieve best practices and work processes
Your profile
- Advanced academic degree in natural sciences
- At least 10 years of regulatory experience in the pharmaceutical industry/biotech including direct experience in leading an NDA in US
- Proficiency in preparing and submitting regulatory documents, including INDs to regulatory authorities, with a thorough understanding of regulatory submission requirements and processes
- Ability to identify regulatory risks and opportunities, proactively assess their potential impact on regulatory approval or compliance and develop mitigation strategies to address them effectively
- Familiar with OPDP requirements is a plus as well as post marketing experience
- Experience within the antiviral/anti-infectives therapeutic area is a plus
- Good organizational, communication and intercultural skills
- Excellent team working
- Continuous striving for innovative thinking and operational excellence
- Capable of adapting to changes creatively, and ability to remain focused in complex situation
- Strong leadership skills with the ability to effectively lead and motivate a multidisciplinary team, foster collaboration, and drive results in a fast-paced and dynamic environment
- Lead by example, demonstrate company values and fostering an environment of transparent and effective speaking up
Why us?
- 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: Competitive comprehensive benefit plan.
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