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Regulatory Affairs Lead (m/w/d)
Linz |
Permanent
Positionstitel: Regulatory Affairs Lead (m/w/d)
Anstellungsdauer: unbefristet
Branche: PharmaFähigkeiten: Regulatory Affairs, API, Life Cycle Management
Idealer Startzeitpunkt: ab sofort
Einsatzort: Linz
Aufgaben:
- Expert and contact person for regulatory issues in the context of the production of active pharmaceutical ingredients (APIs) at the site as well as in the global company network
- Coordination and preparation, review and ongoing updating of filing dossiers (CMC, CEP, Drug Master File, etc.) for active pharmaceutical ingredients (APIs) in accordance with the respective national and international regulations
- Self dependent regulatory support of products and projects (development and transfer projects) as
- well as location-relevant regulatory activities (e.g. Site Master File)
- Support of customers on regulatory topics like coordination of submission strategies, support in the approval process, regulatory evaluation of change control documents, etc. with authorities (FDA, EMA, PMDA, ...)
- For own products: Submission of the required documents to the authorities in compliance with the respective requirements and systems (e-submission, etc.)
- Responsible for the system for the electronic archiving of submission documents
- Enjoy working with people in a dynamic environment
Qualifikationen:
- Completed scientific studies or college of higher education (chemistry, pharmacy, etc.)
- Several years of experience in the field of regulatory affairs in pharmaceutical industry, preferably in the API business
- Experience in handling projects is an advantage
- Strong process thinking, assertiveness and initiative
- Good command of English and good knowledge of MS Office
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Marco Bannier
13030
Pharma
ab sofort
n. A.
Permanent
