Search for Jobs and Projects within the Life Science Industry
search
reorder

Manager Regulatory Affairs (m/w/d) (DE)

[12340]
API, Regulatory Affairs, CMC

Positionstitel: Manager Regulatory Affairs (m/w/d) Anstellungsdauer: unbefristet Branche: Pharma Fähigkeiten: API, Regulatory Affairs, CMC Idealer Startzeitpunkt: 23.11.2022 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

Positionstitel: Manager Regulatory Affairs (m/w/d)
Anstellungsdauer: unbefristet
Branche: Pharma
Fähigkeiten: API, Regulatory Affairs, CMC
Idealer Startzeitpunkt: 23.11.2022
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

map Linz date_range 23.11.2022 update Permanent
Direct contact

Marco Bannier

Senior Consultant
mail m.bannier@aristo-group.com
phone +49 89 599 1827 200


Not the right fit for? Send us a message!

You couldn't find the right fit for you? Just send us your contact data and a short description of your profile, and we will get back to you immediately to discuss the next steps.