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Regulatory Affairs Specialist
1 week ago
Job Description:
Main Responsibilities
- Perform regulatory duties such as product registration, relevant lifecycle management (e.g. variation submissions) and contribute to overall regulatory strategy for assigned markets
- Regulatory documents and dossiers gap analysis, compilations and submission
- Responsible for Regulatory monitoring and analysis of new or updated local legislation and for assuring intime registration in the relevant countries.
- Ensure processes are executed in line with global standards
- Supporting development of regulatory strategies and plans to achieve business objectives, and ensuring alignment with global regulatory affairs objectives.
- Providing regulatory advice and guidance to internal stakeholders (e.g. business development, sales & marketing)
Requirements:
- Relevant Bachelor's Degree (e.g. Pharmacy, Biomedical Science)
- 13 years' experience in the pharmaceutical industry with demonstrated success in pharmaceutical product registration and lifecycle management
- Registered Pharmacist is an added advantage.
Interested Applicants
Principal Consultant:
Cheong Yee Yin |
Registration Number:
R | EA
License Number: 17C8502
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