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Regulatory Affairs Lead (m/w/d) (DE)
[13030]
Regulatory Affairs, API, Life Cycle Management
Positionstitel: Regulatory Affairs Lead (m/w/d) Anstellungsdauer: unbefristet Branche: Pharma Fähigkeiten: 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
- 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
- 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
Marco Bannier