Global Pharmaceutical Company
Director, Regulatory Affairs（部長）
Acts as a supervisor of new regulatory staff, driving the submission globally for assigned products, preparing regulatory strategies and evaluating risk assessment, liaison with country Regulatory Managers, interactions with the relevant manufacturing sites.
- Responsible for driving the submission globally for assigned products: approvals and renewals according to marketing needs, managing the preparation, content and format of the submissions
- Liaison with health Authorities and internal and external Experts, with country Regulatory Managers, interactions with the relevant manufacturing sites
- Responsible for driving clinical trial applications
- Providing data packages according to local requirements, Preparations of prescribing documents ( SPCs, Package inserts, labels)
- Preparing regulatory strategies and evaluating risk assessment. Evaluation and assessment of regulatory requirements for variations, extensions and New MAAs .
- Due diligence participation
- Providing advice on ICH/Intercon regulatory legislation, support intercom group
- Data entry (GRAB), document handling (REAL)
- Responsible for continuously development knowledge and finding innovative solutions to regulatory problems
- Monitoring and training of new regulatory staff
- A degree in Life Science or Pharmacy
- 5-10 years experience in Regulatory Affairs or equivalent
- Perfect knowledge of current rules and procedures for product registration
- Fluency in English and local language
- Good computer skills
- Good Negotiation skills
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