Associate 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 company compliant on emerging EU legislation and processes has led to the need to create this new position. The Associate Director will work independently and take over leadership in direct interactions with EU Regulatory agencies as well as business partners and stakeholders. This role will be focused on supporting development activities and managing teams in the area of infectious disease (including COVID-19, Ebola) and oncology.
What will your tasks as "Associate Director EU Regulatory Affairs (m/f/x)" be?
- Representation within the EU regulatory landscape, including the European Medicines Agency (EMA) and EU National Agencies. Additionally, collaborate with the alliance partners when necessary to ensure effective communication and collaboration
- Take on the responsibility of planning and ultimately leading processes and strategies related to Marketing Authorization Applications (MAA) to ensure timely product approvals with competitive labeling.
- Execute clinical trial applications for assigned programs and provide guidance and leadership to team members responsible for these applications.
- Take on leadership responsibilities and oversee the growth and development of team members within the EU regulatory team
- Provide support to department liaisons in addressing project-specific communications and issues. This includes assistance with agency meetings, responses to challenges related to Clinical Trial Applications (CTAs), and oversight of Contract Research Organizations (CROs)
- Stay vigilant in monitoring emerging legislation and guidance within the EU regulatory landscape. Contribute to ensuring company-wide awareness and compliance where applicable.
- Ensure that any emerging issues are promptly reported to EU regulatory leadership.
Your requirements as "Associate Director EU Regulatory Affairs (m/f/x)"?
- Degree within a scientific field
- 8+ years' experience in regulatory affairs, with a primary focus on guiding products through the clinical development process.
- Experience in managing and developing staff members is desirable.
- Familiarity with interactions with the EMA, including scientific advice, orphan designation, and Pediatric Investigation Plans (PIPs).
- Preferred experience in shaping EU regulatory strategies for infectious diseases.
- Ability to negotiate and concisely express clear positions to stakeholders at all organizational levels.
- Direct experience in working with national regulatory agencies and leading face-to-face agency meetings.
- 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!