Regulatory Affairs Specialist

General Summary

Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in Singapore, Malaysia and rest of ASEAN countries

 

• Determine and communicate submission and approval requirements.
• Participate in new product development teams to provide input and expertise on regulatory requirements, determination of global regulatory strategies, review and approval of documentation to support regulatory submissions worldwide.
• Assess the acceptability of documentation for submission filing to comply with regulatory requirements for clinical trials, marketing applications and corporate goals, to secure submission approval.
• Monitor and assess impact of changing regulations on submission strategies.
• Compile, prepare, review and submit regulatory submission to authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned   
• Review and approve advertising and promotional items to ensure regulatory compliance.
• Provide support to requests from post-market clinical studies

Required Key Skills / Qualifications:

• Degree holder with 1-3 years of regulatory field experience in Singapore and ASEAN countries
• Ability to build good relationship with internal and external customers 
• Good computer skills
• Strong team spirit, independent, diligent and strong contributor

Interested parties, please click on APPLY button.

Alternatively, you can share your CV at joleyn.chin@randstadsourceright.com.sg 

EA License: 94C3609 

Reg No: R1440247