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Job Details

Regulatory Affairs CMC Specialist

Company: Docs Global (Continental Europe)
Location: Amsterdam,Netherlands
Reference: Ref AS-020427
Closing Date: 28 Feb 17
Type: Contract
Salary (£): Competitive
Benefits: Excellent & Comprehensive

Job Summary:

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.

Job Requirements

- 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

Remuneration & other details

For interest or more information contact:

Apply for this job: Regulatory Affairs CMC Specialist

Contact Information:

Address:  Head Office
2 Globeside, Globeside Business Park
Website:  Visit Our Web Site

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