Product Registration: Manage the registration process for M&E products with regulatory authorities, including preparation and submission of documentation, responding to inquiries, and ensuring timely approval.
Develop and maintain QA frameworks, templates, and tools to standardize the review process and enhance quality outcomes. Identify process and control gaps, recommend enhancements, and track remediation actions to completion.
Lead and contribute to local process improvement initiatives that strengthen the effectiveness of Regulatory Affairs, Quality Assurance, and other impacted departments.
Risk Assessment & Advisory: Conduct risk assessments on new ingredients or products and translate complex regulatory changes into actionable business guidance.
Coordinate and process representative applications and notifications, including the preparation of supporting documentation, internal approvals and submissions through MAS TX Portal, SGX Members Portal and other applicable regulatory systems.
Lead and contribute to local process improvement initiatives that strengthen the effectiveness of Regulatory Affairs, Quality Assurance, and other impacted departments.
An exciting new opportunity has come up and a global pharmaceutical company is seeking an experienced Regulatory Affairs Executive to join their expanding team in Singapore. The successful incumbent will manage all local regulatory activities and report to the Regional Manager.As the RA Pharmacist, you will ensure existing & new product registrations are carried out in accordance to business requirements. You will establish strong relations with local regulatory authorities and also champion effective PV report procedures.You should have at least 1 years’ of regulatory experience within the pharmaceutical industry and a Bachelor’s Degree in Pharmacy. Singapore Registered Pharmacist is an advantage.
Receive, process, assess and report adverse events, product complaints and other safety information in accordance with local and global regulatory requirements.
Coordinate Operating Grant, Recurrent Grant, Pre-Operating Grant and language programme grant submissions, including supporting documentation and internal clearance.