Our client, a pharmaceutical company in Basel is looking for a : Regulatory Affairs Coordinator
Duration: It's a 12 months contract.
Location: BaselYour Tasks:
You will support the team operationally with coordinating regulatory requests and archiving documents;
You are responsible for tracking the submission and approval activities. You will be working in close collaboration with Regulatory Operations, CMC and Regulatory Strategy Teams to support the filing activities worldwide.
- Ensure accuracy, completeness and consistency of electronic tracking records on regulatory filings
- Obtain appropriate documentation to support submission of regulatory documents and other documents from different stakeholders in the company
- File new or revised documents electronically into the company's software systems, and assist in maintaining current regulatory documents in these systems
- Coordination of requests, following up with stakeholders and managing mini-projects related to regulatory filings, requests for information, translations etc.
- Create and maintain department spreadsheets as needed
- Participate in process improvement initiatives within GRS or the International HQ as required
- Maintain an effective archiving and submissions/approvals tracking records
- Bachelor degree in life science or related area
- Minimum 2 years of experience in the Pharmaceutical industry
- Between 1-2 years of experience in Regulatory Affairs or Clinical Operations
- Experience in the preparation/submission of regulatory documentation is a plus
- Basic knowledge of the drug development process and regulatory requirements (knowledge of ex-Europe regulatory environment would be an advantage)
- Ability to work with different systems and tools and follow processes
- Ability to work on several projects concurrently, ability to prioritize
- Project management skills
- Excellent knowledge of English, spoken and written
- A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious and Collaborative
Swiss work permit required
Randstad (Schweiz) AG