If you are an experienced, passionate CMC Regulatory Affairs professional contractor/freelancer, with immediate or impending availability for a new contract, our client is looking for an individual experienced with Regulatory expertise to provide timely preparation of CMC Regulatory documentation and contribute to global Regulatory Submissions and Strategies. You should demonstrate competencies in strategic thinking and the ability to embrace Regulatory principles and processes.
Within this role you will:
- Deliver development and implementation of CMC Regulatory Strategy
- Implement Global CMC Submission activities for assigned projects and products
- Produce high-quality strategic project documentation and presentations
- Take accountability for relations with Health Authorities
- Think strategically and methodically to determine risks and lessons learned for Regulatory activities
You will bring to the role:
- Robust experience delivering strategic input from a global perspective
- Demonstrated expertise of Regulatory principles, alongside reliable Regulatory drug development and lifecycle maintenance
- Solid competence and experience with NCEs
- Experience and confidence in leading Health Authority interactions
- An extensive grasp of Regulatory procedures
- Proven experience working strategically with a CMC environment
In return you will receive:
- A role in a leading organisation
- The capacity to work in an energetic, ambitious team
- Recognition and reward for exceptional achievements
- The ability to grow within a compassionate and development orientated organisation
If you have the skills and experience for this opportunity and the ambition to take on this position, please call Alouette for further details or email your CV today.
Contact Alouette at +41 615 880 066/ 0615 880 066 or email@example.com.
Alouette is a Search Consultant at Haybury Search covering Europe, UK, North America, and Asia.
This job advertisement is placed by Haybury AG, Teichgässlein 9. 4058 Basel, Switzerland. In the course of this job offer the selected employee will be employed for hiring of services. All preselected.