Regulatory Intern

Location: City of Singapore

Company

hirify.global develops medicines and works to improve healthcare outcomes through pharmaceutical science.

What you will do

• Assist the Regulatory Manager with worldwide pharmaceutical regulation and API regulatory filings, including CEP, CMC, DMF, NDA, JNDA, NDS, and MAA submissions.
• Maintain and update regulatory files and databases while ensuring accurate and timely documentation.
• Support regulatory inspections and audits by preparing documentation and providing on-site regulatory assistance.
• Monitor regulatory performance data, identify trends and issues, and support action plans.
• Support manufacturing licence, GMP certificate, and site master file activities.
• Support SOP revisions, change control, and continuous improvement initiatives related to quality and regulatory assignments.

Requirements

• Interest in pharmaceutical regulation, regulatory affairs, and quality-related assignments.
• Ability to maintain accurate regulatory documentation and databases.
• Ability to support inspections, audits, change control, and compliance activities.
• Willingness to work in City of Singapore on a full-time basis.

Culture & Benefits

• Equal-opportunity environment that values people from diverse backgrounds.
• Work connected to pharmaceutical science, better medications, and improved healthcare outcomes.
• Exposure to global regulatory processes and practices.