B. Braun Pharmaceuticals SA
Jr. Manager Global Regulatory Affairs CMC
B. Braun is a major international company and a leading provider of the global health care market.
The Global Regulatory Affairs department and Pharmaceutical Product Lifecycle Management is an important part of the organizational structure of B. Braun.
Internally it lies at the interface of drug development, manufacturing, marketing, pharmacovigilance and clinical research. Externally it is the key interface between the company and the regulatory authorities.
In our Global Regulatory Affairs Pharmaceutical department, we are developing regulatory strategies and managing regulatory procedures / marketing authorizations successfully.
The scope of duties includes compilation and maintenance of the quality documentation in the registration dossier following international directives and requirements, the internal SOPs, GRA and Lifecycle Management strategy.
Your main tasks:
- Prepare and obtain the quality documentation of the registration dossier as support for RA procedures (new registrations, renewals, variations)
- Assessment of the quality documentation and assure scientific support in case of request for further information coming from health authorities for RA procedures.
- Maintain the registration dossier in accordance with Document Management System requirements
- Scientific support from CMC point of view in Lifecycle Management of medicinal products;
Your profile:
- University degree (pharmacy, chemistry, biology)
- Optional (bonus): Experience in the pharmaceutical documentation and regulatory affairs field
- Microsoft Office skills (Word, Excel, PowerPoint)
- Very good English skills (business fluent)
- Analytical and structured way of thinking and working
- Organized with good communication skills,
- Willing to travel internationally
- Team work skills
Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary and benefits, all within a dynamic family-owned company.