Job Description

Overview

• Position: Regional Regulatory Affairs Manager
• Portfolio: Consumer Health | Pharma
• Reporting to: Global RA (HQ: EU)

Main Responsibilities

As a RA Manager, you will collaborate with various functional leaders and external partners to align regulatory considerations with business objectives. Additionally, you will lead regulatory operations, oversee product lifecycle management, and ensure compliance with labeling requirements. This position requires regional experience in regulatory affairs and strong leadership and communication skills.

• Develop and implement regional regulatory strategies to achieve timely approvals of new products and variations, aligned with business objectives and global standards.
• Collaborate with cross-functional leaders to incorporate regulatory considerations into initiatives across commercial activities, medical affairs, marketing, and supply chain.
• Establish effective relationships with global regulatory affairs teams, affiliate regulatory managers, and partner regulatory managers.
• Collaborate with partners to develop and maintain relationships with health authorities in the region.
• Stay updated on industry regulations, policies, trends, and opportunities by participating in industry associations and conferences.
• Monitor regulatory changes and assess their impact, identifying opportunities and mitigating potential business risks.
• Ensure compliance of product packaging materials with local labeling requirements and manage packaging revisions.
• Review promotional and non-promotional materials from a regulatory perspective for product campaigns and marketing activities.

Requirements

• At least 5 - 8 years of experience in regional regulatory affairs, preferably in a regulated industry such as pharmaceuticals or medical devices.
• Bachelor\'s degree in a health-related science field
• Strong organizational, planning, and communication skills, including the ability to build and maintain relationships with stakeholders.

Interested applicants

If you have the required experience and qualifications, along with a proactive mindset and the ability to thrive in a dynamic business environment, we encourage you to apply. Please submit with your updated resume, highlighting your relevant skills and experiences, and demonstrating your understanding of regulatory affairs in the APAC region. Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502