CMC EU Regulatory Manager -Pharma - RM Group AG
CMC EU Regulatory Manager – Pharma vacancy for a globally operating Glattpark based company in the Pharma sector.
Your tasks:
- Designing and implementing comprehensive EU regulatory strategies to support product approvals and patient access
- Working closely with regional Market Access and Integrated Franchise Teams to ensure regulatory strategies are integrated into wider business goals
- Managing regional regulatory submissions, coordinating with health authorities, and ensuring timely approvals through product lifecycle
- Offering strategic advice to internal teams, ensuring that development programs comply fully with EU regulations and operate efficiently
- Overseeing CMC regulatory responsibilities, including managing post-approval changes and product updates to maintain EU compliance
Your experience/knowledge:
- In-depth understanding of EU regulations and guidelines for drug and biologics development, including post-marketing requirements
- Strong grasp of regulatory affairs concepts and their impact across departments and global functions
- 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
Your soft skills:
- Excellent comprehension skills with attention to detail
- A high degree of self-organisation and time management
- Analytical and solution-orientated thinking
Location:
Glattpark, Switzerland
Work setting:
Hybrid
Sector:
Pharma
Start:
11/2024
Duration:
06+ MM
Workload:
100%
Ref.Nr.:
BH 22293
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are warmly welcomed, we will support you all the way.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
