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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 in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a

 

Regulatory Affairs Specialist CMC (m/f/x) 

 

Tasks & Responsibilities: 

 

  • Independent, self-driven planning, writing and compiling of CMC documents (in particular module 2.3 and 3) of assigned dossiers ensuring their compliance to regulatory requirements worldwide and according to agreed timelines
  • Provide CMC support to development projects as well as for answering questions of health authorities
  • Manage document lifecycle within the Regulatory Information Management System
  • Ensure CMC documents are compliant at all times meeting GMP and other regulatory requirements
  • Keeping abreast with changes to the regulatory landscape and requirements and communicate relevant changes to internal stakeholders
  • Close cooperation and communication with other departments, consultants, CMOs as well as with affiliates, including pro-actively advising on potential regulatory risks and recommending compliant actions
  • Forecast expected costs & required resources of CMC regulatory activities and adhere to the agreed budget
  • Actively contribute to important department deliverables such as strategy development, compliance activities, improvement of intra- & interdepartmental collaboration, optimizing internal process & standards etc.

 

Requirements: 

 

  • University degree in pharmacy, (bio)chemistry or other life science; Master of Drug Regulatory Affairs is a plus
  • At least 2 years of professional experience in Regulatory Affairs in the pharmaceutical industry with an emphasis to CMC activities
  • Excellent knowledge of the technical & regulatory requirements (incl. pharmaceutical analytics, pharmaceutical technology, etc.) for dossiers of medicinal products around the globe (EU, ICH and others)
  • Experience in working with regulatory information management systems & databases
  • Accurate, analytical, independent, integrative and responsible working practices, value-oriented & entrepreneurial thinking and acting
  • Demonstrated excellent organization and project management skills, ability to work in a team and to complete tasks in a detail-oriented manner with high standard despite tight deadlines
  • Excellent English communication skills (both oral and written; German and further languages an advantage); able to communicate effectively to convey complex technical information to various internal stakeholders and to discuss/present expert matters confidently

 

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 an 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!