Regional Regulatory Affair Speciality - Pharma/ Medical Device
Recruit Express Pte Ltd| Date Posted: 28-Dec-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
Bachelor's / Honours
- Maintain the regional overview of country registration status and provide periodic status update as appropriate.
- Assist in the development, review and implementing regional regulatory and quality processes/procedures based on corporate and regional requirements, to enhance cross-departmental activities.
- Liaise with overseas affiliates and distributors pertaining to Regulatory Affairs activities, including compile and prepare regulatory documentation for submission to local authority, product registrations, variations to existing products, license renewals, etc.
- Managing compliance of products in accordance with existing regulations and guidelines.
- Update and maintaining all product registration license in the region and initiate renewal according to the country’s stipulated timeline.
- Coordinate and provide assessment to market responses for information requests and change management assessment.
- Keep abreast of regulatory change and trends to ensure compliance with local regulatory requirements and advise global RA teams on impact.
- Support global and local initiatives and projects.
- Participate as required in quality and regulatory training, seminars relating to area of work.
- Minimum 3-4+ years’ pharmaceutical industry experience in the Asia region.
- Pharmacy, medical or relevant science degree with good pharmacological/ pharmaceutical chemistry/ clinical knowledge Experience in working in regional regulatory affairs in a multinational pharmaceutical company (Desirable)
- Experience in working in regional regulatory affairs in a multinational pharmaceutical company
- Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in Asia Pacific and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of pharmaceutical products, medical devices and cosmetic products.
- Strong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range health care product portfolio.
- Understanding of matrix organisational issues and ability to communicate to multiple stakeholders to facilitate achievement of key strategic objectives.
- Demonstrate strong interpersonal, communication, influencing and engagement skills.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd