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!