125 days ago on aurismedical.com

Senior CMC Regulatory Affairs Manager (80-100%)

Auris Medical AG

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 Please refer to JobSuchmaschine in your application

Senior CMC Regulatory Affairs Manager (80-100%)


Senior CMC Regulatory Affairs Manager (80-100%)

Auris Medical is a Swiss biopharmaceutical company dedicated to developing injectable therapeutics for inner ear disorders such as acute tinnitus or acute hearing loss, an area of great unmet medical need. Our most advanced clinical development programs are currently in phase III. We are a dynamic, rapidly growing team based in Basel that is primarily focused on project management and working with an international network of partners. Our shares are listed on Nasdaq.

We wish to reinforce our Regulatory & Quality Affairs team with a

Senior CMC Regulatory Affairs Manager (80-100%)

Your responsibilities will include:
  • Proactive and efficient management of all CMC regulatory aspects of assigned development and marketed compounds including cross-functional leadership of major CMC submissions (NDA, MAA)
  • Assurance of compliance of CMC development of assigned compounds with regulatory requirements
  • Lead CMC specific interactions with regulatory authorities in collaboration with line manager
  • Ongoing advice and input regarding CMC regulatory requirements and effective collaboration with e.g. R&D and supply functions
  • Interactions with health authorities, vendors and potential partners
  • Management of CMC regulatory project budget
Your profile:
  • University degree in life sciences (chemistry, pharmacy, biology)
  • A minimum of 7 years’ industry experience and at least 5 years of experience in CMC global regulatory affairs
  • Experience with management of CMC aspects of submissions (IND, NDA, MAA)
  • Good communication and organizational skills
  • Strong analytical skills, capability to work independently, as well as in a team and lead cross-functional projects
  • Fluent in English (good knowledge of German is a plus)
  • Excellent command of Microsoft office applications
  • Swiss citizenship or work permit
 We offer:

We offer you an interesting and multifaceted job in a dynamic and international environment and in an exciting novel therapeutic area. You will have the opportunity to participate in a first in class filing in a novel therapeutic area and shape our CMC regulatory strategy. You will report to the Head Regulatory & Quality Affairs. Our offices are centrally located in the city of Basel.

Please submit your application (with all supporting documents) electronically to:
Auris Medical AG
Dr. Andrea Braun-Scherhag
Head Regulatory & Quality Affairs
Falknerstrasse 4
4001 Basel
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Senior CMC Regulatory Affairs Manager


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