Adrenomed AG is a privately owned, latest stage innovative biopharmaceutical company based in the Berlin area. It is specialized in preserving vascular integrity in life-threatening conditions and is committed to precision medicine. The main focus is on sepsis and septic shock.
Currently, we have completed a Phase 2 trial in septic shock and are planning to start a global pivotal trial leading to market authorization.
We would never have come this far without our enthusiastic, creative, and highly motivated colleagues who are willing to grow and work in a dynamic environment. Exactly these colleagues are ready to welcome you to the team and support you from day one. We offer flat hierarchies and the possibility to directly contribute to the development of the company while also providing a competitive salary.
We are currently looking for a Head of Regulatory Affairs f/m/d reporting to the Chief Medical Officer. This key role is a member of the Senior Leadership Team (SLT) and will work closely with the Chief Medical Officer, the Executive Leadership Team (ELT), the clinical operations team, CMC and across all key functions and departments.
- Develop and implement regulatory strategies for Marketing Authorization Applications and subsequent maintenance activities of Adrenomed AG’s development products in EU and US, including the development of pediatric development plans.
- Coordinate the generation and submission of dossiers for clinical trial authorization and marketing authorization application in the EU, US and other regions
- Be an expert in international regulatory aspects to effectively support all other units of the company.
- Represent the Adrenomed AG Regulatory Affairs Department during Agency inspections and meetings with external partners or scientific key opinion leaders.
- Provide regulatory input to strategic development plans and clinical investigation plans.
- Monitor changes in regulatory laws and regulations and evaluate the impact on the pharmaceutical industry in general and on the business of the Adrenomed AG in particular.
- Develop active networks for the Regulatory Affairs Department with internal and external stakeholders.
- Manage and ensure contractual agreements with external providers for regulatory services.
- Act as a contact and escalation point for regulatory matters, identify internal needs for training and new/changed procedures, as well as develop solutions to address knowledge gaps within the organization.
- Plan and control the financial budget for the regulatory affairs activities
- Ensure relevant regulatory SOP’s are developed and implemented to effectively support the needs of the Adrenomed AG business.
- Master´s Degree or PHD advanced degree in appropriate scientific discipline
- Minimum 5+ years of global regulatory experience in drug development and life-cycle management
- Prior experience leading health authority interactions; experience leading or supporting major submissions from filing through approval
- Experience in coordinating regulatory affairs activities in a small company environment along as with a “hands on” mindset
- Demonstrated leadership capabilities and ability to think strategically
- Demonstrated ability to integrate regulatory science with scientific/clinical knowledge
- Demonstrated track record of working in a multifunctional matrix biotech environment
- Experience in managing multiple projects and proactively plan
- Aptitude to experiment, learn and adapt- We balance our expertise with curiosity, continuous learning, adaptability and a commitment to never give up, whether we succeed or fail.
- Experience of all phases of the drug development process in Regulatory Affairs would be a plus
- Experience in working with strategic partners/cross company collaborations
- Experience in partnering with business development in due diligence efforts
- Excellent communication skills in English and German
- High level of commitment, flexibility & perseverance
Our commitments to you
- Opportunity to be part of a dynamic biotech company that could bring the first treatment ever for sepsis to the market
- Innovative and international environment
- Close collaboration with other teams throughout the company and with external service providers
- Flat hierarchy, direct reporting to the CMO & fast decision times
- Implementation of your ideas
- Fair and competitive salary
- Good connection to Berlin’s public transport
- Up to 3 days of remote work per week
If you like this role and think that you would be a suitable candidate, don’t hesitate! Send us an application and CV to email@example.com