What is the full form of CMC

Regulatory CMC Manager (M / F)

JOB INFORMATION

function
Regulatory CMC Manager
Location
Basel
Start of work
As soon as possible
working hours
Full time
type of enployment
Indefinitely
Contact
HR team Basel
+41 61 205 62 00
[email protected]

ACTIVITIES

  • Coordination, preparation, review and timely creation of high quality CMC approval documents for new submissions and variation dossiers of national and international projects
  • Replying to deficiency letters from regulators
  • Ensuring regulatory compliance and consistency according to external and internal regulatory requirements and quality standards
  • Elaboration of the regulatory strategy from the RegCMC perspective
  • Contact person for RegCMC expertise in cross-functional teams
  • Development and maintenance of the relationships with regulatory authorities with regard to pre-submission strategies, possible registration paths, compliance test requirements as well as clarification and follow-up of the dossiers already submitted
  • Development and implementation of employee training in relation to current regulatory standards and best practices
  • Supervision and training of interns within the Regulatory Affairs department

CONDITIONS

  • Completed university degree (MS or PhD) in the field of pharmaceutical science, chemistry, biology or related natural science
  • First experience in a Pharma Regulatory CMC environment
  • Experience with biologics products is an asset
  • Good written and spoken English

 

We give career starters a chance in particular!

The agap2 Team is at your side. You will be accompanied and supported by us and we will prepare you for the next step in your career agap2 in front. Furthermore, you can expect a dynamic working atmosphere, extensive training opportunities and the prospect of experience with various customer companies from agap2 Develop your individual career. We combine this flexible career structure with the security of a permanent position with a salary that is customary in the market.

We look forward to receiving your complete application with a cover letter and a current curriculum vitae
[email protected]