Jr. Manager GRA Variation Management

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 liaises at the interphase 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 all necessary activities to apply for variation in order to maintain up to date the registration dossier of already approved products.

Your main tasks:

• Prepare and submit documentation for variations in order to maintain up to date the registration dossier of already approved products.
• Evaluate local requirements for regulatory procedures.
• Prepare response documentation as requested by health authorities for different regulatory procedures
• Prepare national documentation in alignment with local and global RA colleagues and other global departments.

Your profile:

• University degree (pharmacy, chemistry, biology or other related studies)
• 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.