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Regulatory Affairs Director

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The company

Our client is a professional Pharmaceutical organization, based in Brussel Belgium. A biopharmaceutical clinical-stage company, specialized in the development and engineering of cell-based therapies.

Role description

The successful candidate will report into the Global Head Regulatory Affairs (located in the US)

Responsibilities

- Stay up to date with regulatory requirements relevant for company pipeline/products
- Develop detailed regulatory project plans and timelines
- Participate as an active team member and provide strategic regulatory advice to cross-functional program and project teams as required on all aspects of Regulatory CMC, non-clinical and clinical aspects during all stages of drug development
- Manage and oversee responses to regulatory authorities’ questions with strict deadlines
- Serve as a liaison with relevant Health Authorities
- Ensure optimal early interactions with relevant Regulatory Agencies and identification and mitigation of regulatory gaps
- Review and provide Regulatory insight into submission-level documents to ensure alignment with company objectives and strategy

Requirements

- Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 8 years in biopharmaceutical / pharmaceutical / biotech industry, in a similar role in Regulatory Affairs; or a PhD in Pharmaceutical Sciences, Life Sciences or equivalent with at least 5 years in biopharmaceutical/ pharmaceutical / biotech industry, in a similar role in Regulatory Affairs
- Experience in coordination, preparation and conduction of global regulatory agency meetings and related materials
- Solid understanding of regulations and guidelines



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SIRE Life Sciences®

Ref. number: 35916
Listed by: SIRE Life Sciences®
Listed on: 18-09-2017
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Permanent
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 Deutschland GmbH

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

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

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

SIRE Life Sciences Consultancy B.V.

Wetenschapsstraat 14B
1040 Bruxelles
+32 (0) 2 588 1277