Cmc Specialist

The Global Regulatory CMC Bausch + Lomb team plays a critical role as part of the strategy for Bausch Health. For this reason, we are currently recruiting for one

CMC Specialist (M/F/x) with Polish language skills

**Purpose**:
Timely preparation and update of pharmaceutical Chemistry, Manufacturing & Control (CMC) documentations for medicinal products with consideration of the current laws and regulations

Processing of official deficiency letters and questions of partners to CMC issues on schedule

Sourcing of relevant information and documents mainly from External Manufacturing Organizations

Responsibility for the completeness and correctness of the CMC dossier

**Reports to**: Head, Global Regulatory CMC - EMEA (located in Berlin)

**Main tasks**:
As part of the European CMC team, you will be in contact with the local Regulatory Affairs teams and the mainly external production site members to provide:
Preparation and updating of the quality part of the registration dossier (CMC)

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

**Your profile**:
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 and/or Russian preferable