Company: Docs Global (Continental Europe)
Reference: Ref AS-020427
Closing Date: 28 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
As the RA Specialist you will support the department activities, executing regulatory compliance activities regarding CMC (Chemistry, Manufacturing & Control) matters within the Global regulatory Affairs.
Roles & Responsibilities of the position
1) Coordination of Compliance processes
2) Executing CMC compliance global strategies, standards and processes, partnering with stakeholders for their establishment, roll-out and maintenance.
3) Participating to process improvement at local level & within the community.
4) Participating to performance measurement of CMC regulatory compliance processes
5) Providing CMC compliance trainings at local level
6) Sharing Compliance RA knowledge
7) Compile and maintain regulatory documentation databases or systems.
8) Participate to relevant boards.
9) Supporting the Implementation of CMC compliance global strategies, standards and processes.
10) Act as point of contact or relay for a specific CMC regulatory compliance matters.
- degree or master in Health Sciences
- A minimum of 3 years in Regulatory Affairs
- Regulatory knowledge
- Good team spirit
- Able to work within a highly complex organisation (matrix structure, multi-disciplinary/cultural teams)
- Strong organization skills
- Good interpersonal, communication, presentation skills
- Effective time management, ability to manage multiple tasks
- Customer focus
- Fluent in written and oral English
- Other local language is a plus
- Working knowledge of electronic tools/systems
For interest or more information contact:
2 Globeside, Globeside Business Park
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