Regulatory Affairs Specialist
1 month ago
Job Summary: Regulatory Affairs Specialist required to ensure compliance with local, state, and federal regulations and laws, with a focus on handling dangerous drugs and supporting the regulatory team.
About Zuellig Pharma
Zuellig Pharma is a leading healthcare services group in Asia, dedicated to making healthcare more accessible. With over 100 years of experience, we have established ourselves as a trusted partner for healthcare companies looking to realize opportunities in Asian markets.
Our focus is on delivering innovative solutions that expand across Distribution, Clinical Reach, Sales & Marketing, Patient Centered Services, and Community Pharmacies. We believe that delivering products is only the first step to capturing the Asian markets, which is why we continue to invest in developing cutting-edge solutions.
Zuellig Pharma is the leading provider of distribution services to manufacturers in the life science industry in the Asia Pacific region. With operations in 13 countries or territories, we have strong market positions, critical mass, broad geographic coverage, and significant potential for continuing growth.
As a Regulatory Affairs Specialist, you will be responsible for:
- Monitoring and controlling all transactions of dangerous drugs
- Securing licenses to handle dangerous drugs
- Ensuring timely and accurate semi-annual reports
- Complying with regulatory requirements of PDEA and DDB on dangerous drugs
- Conducting regular inventory counts of dangerous drugs
Key Requirements:
- Registered Pharmacist with a minimum of 1 year of experience in a similar capacity
- Awareness of regulatory requirements and current regulations
- Knowledge of basic principles of various GxP standards, such as ISO 9001-2015, GSDP, GMP, GCP, and GPV
- Ability to handle dangerous drugs
- Good communication skills and MS Office application literacy
Desirable Competencies:
- Good coordination skills
- Ability to work and deliver under pressure
- Exercise judgment and decision-making
- Hard-working and fast-learning
- Flexible working hours as required by projects and group goals
- Dependable and reliable
- Ability to work with minimum supervision
- Keen to details
- Dedicated and flexible
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