Oncology Regulatory Strategy Lead

MSD Malaysia; Northern (KY); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks an Associate Director Regulatory Liaison to support oncology products within a global regulatory team.

The role emphasizes collaboration, strategy development, and preparing regulatory submissions while coordinating with various functions across regions. The candidate will work hybrid, engaging with global leads and cross-functional teams to drive submissions, lifecycle activities, and agency communications.

Qualifications

• Bachelor’s or higher degree with relevant pharmaceutical experience.
• Experience in regulatory affairs for oncology products preferred.
• Strong communication and collaboration skills with global teams.

Responsibilities

• Assist in regulatory agency communications and submissions, including INDs and pediatric plans.
• Help develop and implement global regulatory strategies for registrations and life-cycle management.
• Coordinate with regulatory operations, clinical safety, labeling, CMC, and other functions.

Skills

Cross-Functional Teamwork

Global Regulatory

Investigational New Drug

Label Development

Life Cycle Planning

Pharmaceutical Industry

Regulatory Submissions

Regulatory Strategy

Regulatory Reporting

Regulatory Communications

Regulatory Documents

Regulatory Filings

Stakeholder Engagement

Education

Bachelor’s Degree (pharmaceutical/biological)

Master’s Degree (pharmaceutical/biological)

M.D./Ph.D. or related doctoral degree

Job description

Merck & Co., Inc. seeks an Associate Director Regulatory Liaison to support oncology products within a global regulatory team.

The role emphasizes collaboration, strategy development, and preparing regulatory submissions while coordinating with various functions across regions. The candidate will work hybrid, engaging with global leads and cross-functional teams to drive submissions, lifecycle activities, and agency communications.