Teamleitung Regulatory Affairs CMC (m/w/d)
Become a part of our team because we are looking for you temporary as soon as possible as

Teamleitung Regulatory Affairs CMC (m/w/d)

Tasks & Responisbilities:

  • Line management of the RA CMC Biofactors team within the Regulatory Affairs Department
  • Planning of all relevant CMC regulatory activities for the Biofactors portfolio
  • Ensure that the CMC dossier parts (CTD Modules 2.3 and 3) are compliant and submission ready
  • Ensure CMC support in the planning and organization of complex approval projects in a European and global context
  • Ensure excellent CMC support to the deficiency letter answering process
  • Manage the assessment of registration dossiers (Due Diligence)
  • Budget and forecast expenses; adhere to budget
  • Manage interfaces und customers of the RA CMC Biofactors team
  • Achieve departmental goals at team level
  • Guidance at CMC-related topics within the company

Requirements:

  • University degree in pharmacy, chemistry or other comparable scientific qualification
  • Min. 5 years of experience in Regulatory Affairs in the pharmaceutical industry
  • Leadership experience
  • Knowledge of pharmaceutical analytics, pharmaceutical technology and pharmaceutical biology and pharmacology, especially against the background of the associated requirements for product approval
  • Extensive knowledge of the legal requirements for drug approvals, with the focus on the technical (CMC) requirements
  • In-depth knowledge of international guidelines and regulations, e.g. ICH
  • In-depth knowledge in the compilation of CMC documents
  • Excellent communication skills and team oriented working
  • Assertiveness, good negotiation skills, ability to work under pressure, reliability
  • Very good command of English (business fluent), German language skills of 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:

We are looking forward to receiving your application!

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.

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.

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

Location:
Böblingen

Position:
Executive

Start of employment:
From now on

Contract form:
Permanent

Required level of education:
Abgeschlossenes Studium

Working-hours:
Full-time

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