![MARTHA TRADE PTE. LTD](https://media.trabajo.org/img/noimg.jpg)
phamacist
2 months ago
Downtown Core, Singapore
MARTHA TRADE PTE. LTD
Full time
Job Title: Pharmacist - Product Registration and Certificate ApplicationResponsibilities: 1. Product Registration: • Prepare and submit applications for product registration to the Health Sciences Authority (HSA) and other relevant regulatory bodies.
• Ensure all product information and documentation meet regulatory requirements and standards.
• Liaise with regulatory authorities to facilitate smooth and timely approval of product registrations.
• Monitor the progress of submitted applications and address any queries or additional requirements from regulatory authorities. 2. Certificate Application:
• Prepare and submit applications for necessary certificates, including Good Manufacturing Practice (GMP) and Certificate of Pharmaceutical Product (CPP).
• Ensure compliance with all legal and regulatory requirements for certificate applications.
• Maintain up-to-date knowledge of regulations and guidelines pertaining to pharmaceutical product certification. 3. Documentation and Compliance:
• Maintain accurate and comprehensive records of all registration and certification processes.
• Ensure that all product information, labels, and packaging meet regulatory and legal requirements.
• Conduct regular audits of product documentation to ensure ongoing compliance with regulatory standards. 4. Liaison and Communication:
• Act as the main point of contact between the company and regulatory authorities.
• Communicate effectively with internal teams, including R&D, Quality Assurance, and Marketing, to ensure timely and accurate submission of applications.
• Provide regulatory guidance and support to internal stakeholders on product registration and certification matters. 5. Continuous Improvement:
• Stay informed about changes in regulatory requirements and industry best practices.
• Identify opportunities for process improvement in product registration and certification.
• Participate in training and professional development activities to enhance regulatory knowledge and skills. 6. Reporting:
• Prepare and present reports on the status of product registrations and certificate applications.
• Keep management informed of any significant regulatory issues or changes that could impact the business.Qualifications:
• Bachelor's degree in Pharmacy or a related field.
• Registered Pharmacist with the Singapore Pharmacy Council.
• At least 3 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
• Strong understanding of regulatory requirements and guidelines for pharmaceutical products in Singapore.
• Excellent organizational and communication skills.
• Attention to detail and ability to work independently.
Summary of role requirements:
- Looking for candidates available to work:
- Monday: Morning, Afternoon
- Tuesday: Morning, Afternoon
- Wednesday: Morning, Afternoon
- Thursday: Morning, Afternoon
- Friday: Morning, Afternoon
- 1 year of relevant work experience required for this role
- Working rights required for this role
- Expected start date for role: 01 August 2024
- Expected salary: $3,000 per month