Regulatory Affairs Liaison (Associate Director)

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

Job Description

The Regulatory Affairs Liaison (Associate Director) role is a broad role encompassing all aspects of regulatory strategy to support countries in region, including clinical, CMC and risk management requirements, and oversight of strategic regional labelling issues.

In this role, the Regulatory Affairs Liaison (Associate Director) has responsibilities including:

• Serves as single POC for specific products for country and HQ.
• Provides regionally focused strategic input to product development across region and across portfolio.
• Contributes to region specific aspects of a development strategy.
• Leads identification of regional specific elements of submissions.
• Owns and leads the overall regional product regulatory strategy, including the corporation and maintenance of regulatory requirements for health authority registration approval.
• Monitors and communicates key strategic issues related to program progress and issues to/from countries and HQ.
• Manage the execution of Health Authority (HA) Response to Questions (RTQ) for both product marketing and assigned applications, and helps ensure HA deficiency letters are appropriately addressed in a timely manner
• Ensures alignment of strategy and priorities for portfolio of products with stakeholders.
• Contributes to development and execution of regional regulatory policy issues.

Qualifications and Skills

• Bachelor graduate degree in Pharmacy, Biological Sciences, Chemistry, or related discipline required with at least 10 years’ experience in Regulatory Affairs. Individual with other relevant qualifications and substantial industry experience, supported by strong working knowledge of Regulatory Affairs or Clinical Research would be considered.
• Outstanding, interpersonal, written and verbal communication skills with strong collaborative skills and the ability to work both proactively and responsively in a fast-paced dynamic environment.
• Solid knowledge/experience with regulatory requirements & processes and registration guidelines for NCEs and product life cycle maintenance, preferably within Asia Pacific region.
• Collaborative team player with strong analytical judgment and problem-solving skills, capable of independently managing complex challenges and resolve issues efficiently.
• Demonstrated ability to assess, prioritize and manage multiple projects, tasks and responsibilities simultaneously.
• Proven ability to work independently and effectively within cross-functional and international teams.
• Strong ability to adhere to strict project timelines and deliverables.
• Highly detail- and goal-oriented, quality-driven and customer-focused.
• Fluent written and spoken English is required.

Required Skills

Ability to Coordinate, Ability to Coordinate, Adaptability, Business Alignment, Complaint Management, Cross-Functional Teamwork, Customer-Focused, Economic Impact Analysis, Employee Training, Exercises Judgment, Legislative Testimony, Liaison Work, Pharmaceutical Regulatory Compliance, Policy Implementation, Prioritization, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Filings, Regulatory Intelligence, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Risk {+ 7 more}

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

11/14/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R421221