Senior Technical Regulatory Manager CMC (m/f)

REFERENZNUMMER:

376226/11

IHRE AUFGABEN:

-Authoring of high quality global marketing applications (NDA/MAA)
-Facilitation of review of dossier including adjudication meetings
-Prepare high quality internal analytical reports
-Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
-Compliance check of internal reports with raw data and regulatory dossier with internal reports

IHRE QUALIFIKATIONEN:

-University degree (preferably Master or PhD) or equivalent in chemistry, pharmacy or relevant engineering discipline
-Experience in small molecules CMC Regulatory or in pharmaceutical development activities (then combined with a strong understanding of regulatory affairs)
-Recent knowledge and experience of health authorities CMC requirements for small molecules products marketing authorization applications is of solid advantage
-Direct experiences with current regulatory trends (examples Quality by Design, genotoxic impurities, starting material selection) are a plus
-Good project leadership skills and experience, including working cross– functionally and cross-disciplines
-Strong prioritization skills, able to work calmly under pressure, happy to work both collaboratively and independently, track record in effective problem solving
-Outstanding interpersonal skills, fluent in English; German is an advantage; direct experiences with working across cultural areas in a global environment is a plus

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager