Adrenomed AG is a privately-financed, clinical-stage biopharmaceutical company with a clear mission: to rescue vascular integrity in order to save the lives of critically ill patients with limited treatment options. The company’s lead product candidate is HAM8101 (enibarcimab), a clinical-stage, first-in-class monoclonal antibody. HAM8101 targets the vasoprotective peptide adrenomedullin, an essential regulator of vascular integrity to treat life-threatening conditions associated with increased vascular leakage, congestion, and shock.
To effectively support Adrenomed’s vision in developing first-in-class medicinal products for patients with an unmet medical need, we are currently recruiting for an experienced and motivated Senior Regulatory Affairs Manager (all genders) for our Global Regulatory Affairs Department, based in Hennigsdorf, Germany.
The perfect candidate
- Holds a Life Science degree, preferably with a Ph.D. in pharmacy or biology.
- Has profound knowledge of drug development and manufacturing of biological medicinal products.
- Has a minimum of 3-5 years of experience in Regulatory Affairs with a pharma company.
- Has proven experiences with EMA central Marketing Authorization Applications and BLA submissions to FDA. First experiences with Marketing Authorization Applications in China are a plus.
- Can manage IMPD/IND/eCTD dossier writing and contribute to Drug-IVD co-development (e.g., Companion Diagnostics).
- Has excellent communication, computer, and project management skills to interact with internal and external stakeholders, incl. regulatory agencies and service providers.
- Has the ability to work independently within the area of assigned responsibility with an analytical and proactive mindset.
As a Senior Regulatory Affairs Manager, you will become part of Adrenomed’s product development team and you will advise your team partners on all regulatory requirements for a compliant drug development process. In your day-to-day work, you will plan and execute or manage regulatory documents and processes during manufacturing, preclinical and clinical development, which are relevant for the regulatory submissions to national and international Health Authorities.
Supported by external regulatory consultants you will work directly with Regulators in the EU, US and China to gain approvals for Adrenomed’s innovative development projects, incl. CTAs, PIPs, Early Access Designations, MAAs, BLAs. Your work will also include the new development, update, or improvement of regulatory standard operating procedures in line with Adrenomed’s internal quality standards and international guidelines.
You will monitor the regulatory landscape for changes in laws and regulations which may impact Adrenomed’s product development. You will establish Regulatory Intelligence to support other internal functions with their specific needs and questions during the product development life cycle.
The position is challenging, hands-on, and cross-functional with interaction with all stakeholders in a developing pharma company. The team is still small and you can build in your own experiences and ideas.
If you like this role and think that you would be a suitable candidate, don’t hesitate! Submit your CV, cover letter, and salary expectation to: firstname.lastname@example.org.