Senior CMC Specialist (m/f/x) | Pharma
Available locations: Berlin/Warsaw/Prague
In this position you will play a key role in the timely preparation and update of pharmaceutical Chemistry, Manufacturing & Control (CMC) documentations for medicinal products with consideration of the current laws and regulations. You will be responsible for the processing of official deficiency letters and questions of partners to CMC issues on schedule, as well as sourcing relevant information and documents mainly from external manufacturing organizations. You will be in charge for the completeness and correctness of the CMC dossier, all will play a key role within the global regulatory CMC department. Your main focus will be around products in Poland, therefore fluency in Polish and English is mandatory!
What are your tasks as "Senior CMC Specialist (m/f/x)"?
- Preparation and updating of the quality part of the registration dossier (CMC, modules 2.3/3)
- Processing and responding of regulatory deficiency letters and obligations (CMC)
- Preparation of quality expertises
- Processing and responding of questions of internal and external departments and partners concerning the CMC part of the dossier
- Integration of Change Control Procedures during CMC documentation preparation
- Acquisition of information and documents for the dossier via external and internal departments
- Cooperation in the workgroups concerning the CMC documentation
- Support of registration projects concerning CMC questions
What profile is required as "Senior CMC Specialist (m/f/x)"?
- Experience in the pharmaceutical industry with multi-annual experience in the CMC field
- Scientific study (Pharmacy, Chemistry, Food chemistry, Biology etc.)
- Organizational talent as well as reliable and structured work style
- High precision combined with goal orientation
- Good abilities in description of complex circumstances
- High abilities in teamwork and communication skills
- Fluent in Polish and English; German welcomed
Information about our client:
Our client is a leading global healthcare company. In addition to contact lenses and surgical instruments, the company also manufactures pharmaceuticals and is uniquely positioned internationally with this range of products. The company employs over 12,000 people worldwide, and over 700 at its second-largest site in Berlin.