Regulatory Affairs Manager
Vor 4 Tagen
As a key member of our team at RMIT Professional Resources AG, you will be responsible for designing and implementing comprehensive EU regulatory strategies to support product approvals and patient access. You will work closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider business goals.
Your Key Responsibilities:
- Design and implement EU regulatory strategies to support product approvals and patient access
- Work closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider business goals
- Manage regional regulatory submissions, coordinate with health authorities, and ensure timely approvals through product lifecycle
- Offer strategic advice to internal teams, ensuring that development programs comply fully with EU regulations and operate efficiently
- Oversee CMC regulatory responsibilities, including managing post-approval changes and product updates to maintain EU compliance
Requirements:
- Strong understanding of EU regulations and guidelines for drug and biologics development, including post-marketing requirements
- Proven experience in managing relationships with Contract Research Organizations and other external partners is highly desirable
- University degree or equivalent experience in a relevant field
- Language skills: English - fluent
Soft Skills:
- Excellent comprehension skills with attention to detail
- A high degree of self-organisation and time management
- Analytical and solution-orientated thinking
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