Manager Regulatory Affairs
Manager Regulatory Affairs
Posted on :
24-08-2025
Employer Active
1 Vacancy
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Job 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 good working knowledge comprehension and applications of APAC regulations
- Demonstrate appreciation and respect for cultural sensitivities especially in cross-country/-cultural interactions
- Manage and oversee teams 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
- Bachelors 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.
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Required Experience:
Manager
Employment Type
Full Time
Key Skills
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