Specialist Regulatory Affairs

What will your job be

As Specialist Regulatory Affairs you will ensure compliance with regulatory agency regulations and interpretations. Furthermore you:

• Prepares responses to regulatory agencies' questions and other correspondence
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
• Are involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
• Provide solutions to a variety of problems of moderate scope and complexity
• Organize and maintain reporting schedules for new drug application and investigational new drug applications

What are we looking for

For the position as Specialist Regulatory Affairs you have a bachelor degree or higher and have more than 4 years experience in Regulatory Affairs. Furthermore you:

• Have experience in dossier development of Module 3 IND/IMPD or MAA/BLA
• Are able to work in a Documentum System
• Have hands on dossier development experience
• Regulatory Affairs CMC guideline knowledge
• Good communication Skills

What do we offer

• Secondment via CheckMark Labrecruitment
• Salary indication from €3.736,- gross per month based on a full-time position
• Position for 40 hours/week
• Dayshift

Where will you work

A large pharmaceutical company dedicated to bringing life-saving innovation to global health.

More information

Ref.nr: 6702