Senior Regulatory Affairs Manager

Abbott Laboratories; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading healthcare company based in Singapore is seeking a Regulatory Affairs Manager to oversee registration projects across the Asia Pacific. The role requires a strong background in regulatory requirements, excellent communication skills, and a commitment to compliance. The ideal candidate will have a Bachelor's degree and extensive experience in regulatory affairs management.

Qualifications

• 10+ years of working experience with 2-4 years in RA management.
• Fluent in English, both spoken and written.
• Strong collaboration with cross-functional teams.

Responsibilities

• Lead regulatory registrations for product shipments.
• Resolve additional information requests from agencies.
• Ensure compliance with registration schedules.

Skills

Regulatory knowledge

Communication skills

Project management

Problem-solving

Education

Bachelor’s degree or above

Job description

Overview

Primary Function / 职责概述

• To operate the registration in compliance for China and select countries in Asia Pacific region
• To ensure the registration schedule to meet the business development requirement

Major Responsibilities

1. Lead and complete regulatory registrations to ensure shipment of product within the Asia Pacific region.
2. Be responsible for registration projects for the designated countries in the region.
3. Solve requests for additional information and issues/questions from regulatory agencies and governments to meet submission requirements.
4. Ensure that new registration projects are scheduled and that we achieve the expected schedule.
5. Ensure the renewal license and change application on time.
6. Provide regulatory intelligence updates for regulations, standards and guidance documents to ensure that the organization takes actions to remain compliant.
7. Provide the requested explanation for regulatory changes and any applicable training to global or local cross group if necessary, from regulatory side.
8. Communicate with cross functional teams such as Quality Assurance, R&D, Marketing, Operations and others as required to ensure that complete and accurate information is submitted for submissions and that regulatory requirements are communicated to the organization.
9. Assist to ensure that the registration procedures and SOPs are clear, concise and aligned with current practices and requirements.
10. Provide related regulatory support to other company personnel.
11. Develop and maintain good relationships with related authorization agencies and relevant industry association to build advocacy.

Requirements

教育背景/要求

• Bachelor’s degree or above
• Above 10 working experience and minimize 2 to 4 years of relevant RA management experiences
• Good English speaking and written and communication skills.