Director EU Regulatory Affairs (m/f/x) | Munich | Pharma
The growing need for EU-specific expertise on the company's development programs as well as to keep the business compliant on emerging EU legislation and processes has led to the need to create this new role. The Director Regulatory Affairs will work independently and provide advanced regulatory input to interactions with EU Regulatory agencies. This role will be focused on supporting development activities for oncology programs with ongoing activities in phase 1 through phase 3 and the post-marketing setting.
What will your tasks as "Director EU Regulatory Affairs (m/f/x)" be?
- Lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
- Collaborate with Development teams and Regulatory senior management to craft strategies tailored to the EU context. These strategies should capitalize on EU regulatory systems and processes, with a particular emphasis on exploring innovative regulatory approaches for our development products.
- Take charge of devising and ultimately guiding processes and strategies related to Marketing Authorization Applications (MAA). This responsibility includes ensuring timely product approvals with unique labeling for a competitive edge.
- Actively oversee the execution of clinical trial applications for specified programs and provide guidance to team members responsible for this critical task.
- Provide necessary support to Business Partners as required, ensuring seamless alignment of the EU regulatory strategy
- Help department liaisons in managing project-specific communications and resolving issues, including active participation in Agency meetings, addressing challenges related to Clinical Trial Applications (CTA), and overseeing Contract Research Organization (CRO) activities as necessary.
- Ensure the timely reporting of emerging issues to EU regulatory leadership for swift and effective resolution.
Your requirements as "Director EU Regulatory Affairs (m/f/x)"?
- Degree within a scientific field
- 10+ years' experience in regulatory affairs, with a primary focus on guiding products through the clinical development process.
- Demonstrated expertise in providing strategic regulatory insights for advancing oncology treatments, particularly those falling within the biologic's domain (e.g., immunotherapy, bispecific, CAR-T therapies).
- Proven history of successfully supporting Clinical Trial Applications (CTA) within the EU, from initial approval to study commencement.
- Hands-on experience in working alongside national regulatory authorities and assuming a leadership role in face-to-face meetings with regulatory organizations.
- Having previously played a role in guiding a product through the approval process in the European Union (EU) is highly advantageous.
- Demonstrated capability to oversee and support the development of team members is a valuable asset.
- Business-fluent written and spoken in English.
Information about our client:
Our client is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. The Company's exceptional capacity to transform scientific discoveries consistently and repeatedly into practical medical solutions has resulted in a multitude of FDA-approved treatments and a robust pipeline of product candidates, the majority of which originated from their in-house research laboratories. Currently, there are around 8000 employees globally with more than 50 being in Munich.
I look forward to your application!