Regional Regulatory Strategy Lead

Merck Gruppe - MSD Sharp & Dohme; Singapore; On-site; SGD 160,000 - 260,000; Full time

Job summary

Merck Gruppe - MSD Sharp & Dohme is seeking a Regulatory Affairs Liaison (Associate Director) in Singapore to shape regional regulatory strategy for clinical, CMC and risk management requirements. You will coordinate with country teams and HQ, lead region-specific submissions, and oversee HA responses to ensure timely approvals.

The role requires 10+ years in Regulatory Affairs, exceptional English communication, and proven ability to manage complex projects in an international setting.

Qualifications

• Bachelor graduate degree in Pharmacy, Biological Sciences, Chemistry, or related discipline required with at least 10 years’ experience in Regulatory Affairs.
• Outstanding interpersonal, written and verbal communication skills with strong collaboration abilities.
• Solid knowledge of regulatory requirements & processes and registration guidelines for NCEs and product lifecycle maintenance, preferably in Asia Pacific.
• Demonstrated ability to manage multiple projects and work independently within international teams.
• Fluent written and spoken English is required.

Responsibilities

• Owns and leads the overall regional product regulatory strategy across product portfolio.
• Serves as single point of contact for specific products for country and HQ.
• Guides region-specific development strategies and submission elements.
• Monitors program progress and communicates key issues to/from countries and HQ.
• Manages HA responses and ensures deficiencies are addressed promptly.

Skills

Coordination

Cross-functional teamwork

Regulatory strategy

Regulatory compliance

Regulatory filings

Project management

English communication

Education

Bachelor's degree in Pharmacy, Biological Sciences, or Chemistry

Job description

Merck Gruppe - MSD Sharp & Dohme is seeking a Regulatory Affairs Liaison (Associate Director) in Singapore to shape regional regulatory strategy for clinical, CMC and risk management requirements. You will coordinate with country teams and HQ, lead region-specific submissions, and oversee HA responses to ensure timely approvals.

The role requires 10+ years in Regulatory Affairs, exceptional English communication, and proven ability to manage complex projects in an international setting.