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Freelance Regulatory Manager

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The company

Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands. A global leader in sustainable antibiotics. Today they develop, produce and sell API's and DP's.

Role description

As Registration Professional you can hit the floor running, start as soon as possible and work fulltime for a period of one year.

Responsibilities

- Preparing, compiling and maintaining the registration dossiers:
o Collection of information and preparation of dossiers
o Evaluation of the CMC data
o Creation of the product information texts
- Submitting the registration dossiers, responses, renewals and variation packages
- Coordinating the regulatory activities
- Contributing to the agreed way of document management
- Contributing to write and review the SOP’s
- Keeping excellent proactive relationships of DSP customers in order to maximize chances of approval.

Requirements

- HBO or academic (WO) level
- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English



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SIRE Life Sciences®

Ref. number: 33921
Listed by: SIRE Life Sciences®
Listed on: 24-08-2018
Country: The Netherlands
Region: Zuid-Holland
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Master
Language: English
Sector: Pharmaceutical
Specialisation: Regulatory Affairs

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

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

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
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SIRE Engineering

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Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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