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Labeling Coordinator / Regulatory Affairs / Temporary / 11 months

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The company

Our client is a professional Pharmaceutical and Biotechnology organisation, based in Zuid-Holland Netherlands. Our client is dedicated to bringing meaningful innovation to global health.

In the organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company.

Role description

The company is looking for a Regulatory Affairs - Labeling Coordinator with cross-regional scope of work. Support LOCs in submitting compliant local labels in time by quality check of labeling documents in EMEA and Asia Pacific.

Responsibilities

Your responsibilities as Regulatory Affairs - Labeling Coordinator are:

- Maintain oversight of compliant labels for EMEA.
- Ensure updates are integrated into the latest available local label in a compliant manner
- Archive/store the local label in English and local language in a central repository
- Initiate content deviation process, if required
- Ensure updates are integrated into artwork in a compliant manner

Requirements

To be successful for this role it is important to have...

- 5 or more years of regulatory experience, labeling experience preferred
- University degree or equivalent by experience
- Previous experience in RA role as Associate, Professional or similar role is of advantage
- Able to influence without authority – experience in a matrix structure
- Able to make independent decisions
- Experience of working in a virtual team and/or global organization
- Multitasking, accurate and conscientious
- Knowledge of regulatory IT systems (especially document management and planning)
- Language capabilities: fluent in English, generic feel for languages

Other information

Full time applicants only. Full year resource approval given, in case of strong performance it is expected further extension could be possible, but no guarantees can be given. We're looking for an individual who is precise, accurate and detail oriented, and able to change priorities as needed. Will be working largely virtually so can work completely remote / from home. Good English needed and a sensitivity to other European colleagues.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Diana Prieto Reyes.


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SIRE Life Sciences®

Ref. number: 47203
Listed by: SIRE Life Sciences®
Listed on: 30-04-2019
Country: The Netherlands
Region: Zuid-Holland
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Quality

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Contact

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