- Decides on local RA strategic and in coordination with local business
management, and regional (and global) RA-Management, including the
preparation of local budgets and the hiring and training of staff operational
matters
- Contributes actively to design, assess and deliver RA strategic options
- Represents BHC as a competent reliable partner to the local Health
Authorities in all regulatory matters, and builds regulatory networking with
national regulators, local industry organizations and key opinion leaders
- Responsible for implementation of NDA/MAA support activities as
agreed with regional RA-Management
- Responsible for submission and approval of clinical trial applications to
ensure timely start and performance of clinical trials in line with local regulations in the framework of the global product development strategy
and planning
- Quality management
지원자격
- B.A. degree or equivalent in pharmacy, pharmacology, chemistry or the biological sciences, preferably Ph.D., M.D., Pharm.D. or equivalent
- Experience in Drug Development
- Fluent in English in writing, listening and speaking
- Leadership
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