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  • Location

    Boxmeer, Netherlands

  • Job title:

    Global Regulatory Affairs Project Leader

  • Sector:

  • Job ref:

    44811

  • Start Date:

    2020-08-27

- Global Regulatory Affairs Project Leader  -

The company

International Pharmaceutical Company (Noord Brabant)

Description

We have an exciting opportunity for a two-year contract for a Project Leader (Senior Specialist) to lead the cross-functional EU Telematics project team.

Responsibilities

  • Lead a multidisciplinary project team in charge of the implementation of the New Veterinary Regulations 
  • Develop and execute project plans to ensure that business processes as well as regulatory information systems and platforms are brought in line with the new EU Telematics landscape as defined by the EMA
  • Maintaining close contact with internal stakeholder groups
  • Assess regulatory impact for approved products
  • Provide clear communication towards project team members and globally impacted colleagues and necessary training 
Requirements
  • experience in Life Sciences with focus on regulatory data management, quality management, manufacturing, supply chain or compliance 
  • experience with EU authorities / registration process and experience with project management
  • knowledge of EU Telematics (IDMP, UPD, SPOR, CESSP)
  • fluency in English
  • experience with regulatory information systems and platforms (CESSP, Veeva) and EU registration processes is an advantage

Other information

Are you ready to take a new step in your career? If you are interested or know someone who is, contact me and upload your CV via the apply button.

Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.