Regulatory Affairs Manager

Company Overview

Nyprax Pharma is a growing Regulatory Affairs Consultancy with 20+ years of experience. We provide expert guidance to ensure smooth regulatory submissions for medical devices, enabling import, distribution, and marketing in Singapore.

Job Summary

You will coordinate and submit regulatory documentation to the Health Sciences Authority, compile and format medical device dossiers, verify reports, and respond to regulatory queries, supporting compliance and timely approvals.

Responsibilities

• Coordinate and submit formatted regulatory documentation online to the Health Sciences Authority (Ministry of Health)
• Compile client dossiers for medical devices and applications according to Ministry requirements
• Format medical dossier documents to meet regulatory standards
• Verify accuracy and validate reports to ensure compliance and quality
• Respond promptly and accurately to queries from the Ministry of Health
• Manage multiple tasks efficiently under pressure while maintaining attention to detail
• Maintain organized filing systems and perform ad-hoc duties as needed
• Demonstrate eagerness to learn regulatory processes and meet submission timelines
• Commit to continuous professional growth and contribute positively to the company

Required competencies and certifications

• Proficient in English to communicate effectively with regulatory authorities
• Competent in computer skills, including Microsoft Office, to prepare and manage documentation
• Ability to learn and apply regulatory processes in the healthcare industry

Preferred competencies and qualifications

• Degree holder with at least 2 years of experience in Regulatory Affairs for Medical Devices or Pharmaceuticals in Singapore or Southeast Asia
• Experience working across multiple Southeast Asian countries preferred

Other Information

Benefits and Work Environment:

• Work location: 59 Ubi Ave 1 Bizlink Centre #07-14 Singapore 408938
• Nearest MRT: Ubi Station or MacPherson Station, 7 minutes walk
• Working hours: Monday to Friday, 9am to 6pm
• Attractive remuneration with KPI bonuses
• Friendly work environment with comprehensive training provided

Compensation:

• Mid-career starting salary: S$4,500/month
• Career growth based on personal aptitude and ambition

• Contact: Bharat Kumar ([email protected])

• Company Website: www.nypraxpharma.com