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Sr. Manager CMC Regulatory Affairs

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The company

Our client is a world-leading pharmaceutical company, with various products about to enter the market

Role description

Sr. Manager CMC Regulatory Affairs

Responsibilities

Coordination of RA aspects concerning the collaboration with CMOs and partners during CMC advancement
Management of document collection for phase III & IV development tasks like CQA assessment, process characterization and validation, as well as control strategy formation
Arrangement of quality sections for BLA & MAA as well as for IMPD and IND
Alignment of filing activities within the CMC team
Tracking of relevant regulatory interactions between the client, external partners, and regulatory agencies
Contribution to meetings as CMC Regulatory Affairs expert for guidance and regulations related to GMP
Observation of regulatory guidance concerning revisions or additions

Requirements

Degree in Life Sciences
Substantial experience in the pharmaceutical or biotechnological industry
At least 3 years of working experience in the fields of GMP and RA, preferably with a focus biologics
Experience with CMC requirements for phase III & IV clinical development and compilation of module 3 submission
Experience in the most recent Regulatory Affairs related processes in development for biologics
Motivated team player with strong interpersonal abilities and a desire to represent CMC-RA in various working groups
Excellent communication skills (German & English)

Other information

Wenn Sie Interesse an dieser Position haben und sich bewerben wollen, füllen Sie das Bewerbungsformular aus, indem Sie auf die Schaltfläche unten drücken oder nehmen Sie Kontakt mit Alina Andretzky auf.


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SIRE Life Sciences®

Ref. Nummer: 48296
Veröffentlicht von: SIRE Life Sciences®
Veröffentlicht am: 18-07-2019
Land: Germany
Region: Bayern
Beschäftigung: Festanstellung
Sachverstand: 3 - 5 Jahre
Standorttyp: Auf locatie
Bildung: Master
Sprache: Deutsch
Sektor: Pharmazie
Spezialisierung: Zulassung

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Kontakt

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