Regulatory Affairs Manager CMC (m/f/d)


We are looking for a

Regulatory Affairs Manager CMC (m/f/d)

Regulatory Affairs Manager CMC (m/f/d).

Tasks and responsibilities:

  • Ensuring the quality of regulatory documentation, with a focus on pharmaceutical quality (Module 3, Module 2.3)
  • Independent preparation and updating of the CMC documentation (Module 3 and Module 2.3) of international registration dossiers
  • Timely provision of CMC relevant documentation for global new submissions and renewals, as well as for quality-related variations
  • Timely response to deficiency letters related to CMC topics
  • Regulatory support of multi-disciplinary projects (e.g. technology transfers, optimizations) for the European and global market
  • Advise other teams and departments on regulatory topics
  • Regulatory assessment of ASMFs

Requirements:

  • Completed science degree in Chemistry, Pharmacy or in a comparable life science field
  • At least two years of work experience in Regulatory Affairs
  • Good knowledge of pharmaceutical regulatory guidelines and regulations
  • Good knowledge of technical requirements with regards to the content of registration dossier
  • Independent, structured, and integrative working style
  • Communicative, dedicated to work and reliable
  • Good knowledge of process and project management
  • Very good computer skills (MS-Office)
  • Very good English in speaking and writing, knowledge of German or other languages of an advantage

What we offer:

  • We offer you a challenging and varied scope of tasks in a dynamic team of a successful, mid-sized pharmaceutical company
  • We offer you exciting projects in an international work environment, with the opportunity to quickly take responsibility and to share your experiences and knowledge
  • In addition to a performance-based salary you receive a comprehensive offer of additional benefits, for example including an occupational pension provision, workplace health promotions, a job ticket as well as diverse training offers

Contact:

If we have aroused your interest, we look forward to your online registration and the submission of your complete application documents on our application portal.

We look forward to you!

We look forward to you!

WÖRWAG Pharma GmbH & Co.KG
Calwer Str. 7
71034 Böblingen

Einsatzort:
Böblingen

Position:
Fachkraft

Beschäftigungsbeginn:
ab sofort

Vertragsform:
unbefristet

Bildungsgrad Mindestvoraussetzung:
Abgeschlossenes Studium

Arbeitszeit:
Vollzeit

Weitere Jobs bei WÖRWAG Pharma GmbH & Co.KG


Ähnliche Jobs