Contract Regulatory Affairs Executive #HZO - Toa Payoh

Duration: To start in May/ June 2025

Job Scope:

• Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians
• Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
• Create local language labels and Instruction For Use in compliance of country regulations before passing them to Supply Chain
• Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etc.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
• Serve as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plans.
• Handle product recall reporting to regulatory agencies, for products exhibiting non- compliance
• Review marketing advertisements to ensure compliance to regulations and submit to FDA for approval

Job Requirements:

• Min. Degree in Pharmacy or any relevant science field
• Min. 1-2 years relevant experience

For interested applicants, please send your updated resume to: melissa@recruitexpress.com.sg

99C4599