
Regulatory Affairs Executive
2 weeks ago
I am currently representing a renowned **Pharmaceutical MNC **with a strong corporate philosophy in championing human health. They are seeking a **Regulatory Affairs Executive **to join their team.
**Job Description**:
- Perform regulatory duties such as product registration, relevant lifecycle management (e.g. variation submissions) and contribute to overall regulatory strategy for assigned markets
- Research regulatory intelligence, assessing and communicating impact to relevant stakeholders
- Prepare and submit regulatory documents and dossiers
- Support distributors and and company affiliates
- Maintain compliance and efficient document control
- Ensure quality assurance and compliance in the company's products, supporting recall and complaint support as necessary
- Participate in internal and external Quality Systems Audits
- Conduct post-marketing pharmacovigilance activities including surveillance and risk minimization strategies
**Requirements**:
- Relevant Bachelor's Degree (e.g. Pharmacy, Biomedical Science)
- At least 2 years experience in the pharmaceutical industry with demonstrated success in pharmaceutical product registration
- Fluent understanding of pharmaceutical regulatory framework
- Experience with quality standards such as GDPMDS/SS620:2016/ISO 13485
- Excellent interpersonal skills and ability to effectively manage internal and external stakeholders
- Responsible and strong ability to work independently, prioritize and work in fast-paced environment
Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502
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