Manager Regulatory Affairs

6 days ago


กรงเทพมหานคร, Thailand DKSH Holding Ltd Full time

Location: Bangkok, TH, TH
- Global Business Unit: HEC
- Job Function: Regulatory Services
- Requisition Number: 190696
- Description:
**Job Summary**:

- Manage APAC region implementation of registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations
- Develop and implement regulatory strategies and action plan of healthcare projects/products

**General Responsibilities**:

- Manage departmental operating budgets and costs according to annual allocation to ensure efficient usage of resources, where applicable
- Manage the implementation of regulatory affairs' policies, procedures and standards to ensure alignment to global DKSH quality policy and local and international quality standards
- Develop and implement registration strategies and action plan of new registrations for responsible products
- Dossier review and regulatory evaluation for new projects/products
- Support responsible countries for product registrations and related regulatory activities
- Act as primary liaison with local regulatory affairs personnel on Regulatory Affairs issues
- Manage to review with local regulatory affairs personnel on Regulatory Affairs' activities and updates to obtain commitment on local regulatory affairs implementation.
- Work closely with regional marketing, supply chain and manufacturers to ensure smooth logistic flow
- Compilation of registration documentation in co-operation with supplier/manufacturers
- Maintenance of RA database of master dossiers, registration status and regulatory requirement
- Maintenance of registration life-cycle of existing products

**Functional Skills and Knowledge**:

- Demonstrate knowledge in quality assurance tools, concepts and methodologies
- Demonstrate good knowledge of regulatory requirements and regulatory compliance of healthcare products
- Demonstrate basic understanding of the Global Harmonized System (GHS), especially ASEAN Harmonization of Healthcare product registrations
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Manage and oversee team’s delivery of teaM/Function goals to drive execution against goals set
- Drive and manage learning and development of team in the area of Regulatory Affairs and DKSH behaviors to achieve teaM/Function goals
- Drive self-learning and improvement in the area of Regulatory Affairs and DKSH behaviors as part of continuous learning

**Education**:

- Bachelor’s Degree or higher in Pharmaceutical Sciences or related field.
- 8-10 years experiences in regulatory affairs of pharmaceutical, medical devices, cosmetics & related healthcare products preferably with regional experiences.

LI-BB1
- Requisition Number: 190696
- Job Function: Regulatory Services



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