Global Project Leader (m/f)

REFERENZNUMMER:

287566/11

IHRE AUFGABEN:

-Define and provide optimal global regulatory strategies to support the development/approval of new drugs and life-cycle management activities for assigned products
-Lead creation of regulatory function plans (identification and assessment of regulatory issues)
-Provide interpretation of relevant Health Authority regulatory guidelines
-Lead global submission planning process, creation, review and finalization of key regulatory documents
-Establish and lead regulatory sub-teams and ensure regulatory support for other countries
-Collaborate closely with the US based DRA partner for regulatory considerations

IHRE QUALIFIKATIONEN:

-Bachelor degree in Life Sciences or PhD
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-In-depth experience in Regulatory Affairs
-Good knowledge of regulatory legislation and guidelines (ICH and EU)
-Experience with EMA and NCA as well as with various types of submissions
-Good understanding of regulatory aspects at all stages of development (from phase I to phase IV)
-Familiarity with clinical trial methodology and statistics
-Excellent project management skills and experience in working with cross-functional and global teams

WEITERE QUALIFIKATIONEN:

Project manager