Regulatory Operations Executive

Cognizant; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading technology company located in Singapore is seeking a Regulatory Affairs Specialist. This role involves the management of regulatory submissions, maintenance of documentation, and formatting of files using specialized software. Candidates should have 1 to 3 years of experience in the pharmaceutical or related industry, with a preference for those having regulatory affairs experience. The position offers the opportunity to work closely with international stakeholders.

Qualifications

• 1 to 3 years of experience in pharmaceutical industry or related industry.
• Preferably relevant experience in regulatory affairs.
• Strong attention to detail.

Responsibilities

• Responsible for global regulatory submission and dossier publishing activities.
• Compile and maintain regulatory documentation.
• Perform high-level formatting of files using client software.
• Conduct peer reviews and support other regulatory activities.
• Interact with stakeholders for report preparation and quality control.

Job description

Role Responsibilities:

• 1 to3 years of experience in pharmaceutical industry / Medical Device / any related industry (preferably relevant experience in regulatory affairs will be an advantage)
• Responsible for global regulatory submission / dossier publishing day-to-day activities and deliverables.
• Compilation and maintenance of regulatory documentation as per the procedure in client repository.
• Performing high level of files’ formatting using the client provided software (creating bookmarks, hyperlinks, file optimization etc.).
• Performing peer-review of work and providing support to other regulatory related activities as per the business requirements.
• Interacting with relevant stakeholders during preparation and quality control of reports and regulatory documentation. #LI-CTSAPAC