Diese Stelle teilen

WÖRWAG Pharma located in Böblingen near Stuttgart is a mid-sized, international pharmaceutical company. As a family-owned company we develop and distribute biofactors and generics. We are represented in more than 35 countries with about 1000 employees.


Become a part of our team because we are looking for you 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

 

We are looking forward to receiving your application!